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Ureteroscopy
Indicated for extrinsic compression of ureter, ureteral obstruction, ureteral trauma, ureteral manipulation, preparation for ureteral manipulation and assistance with stone fragment passage.
Contraindications
Contraindicated for poor surgical risk patients, unexplained hematuria and un-repaired ureteral avulsion.
Warnings
For single use only. Do not reuse, reprocess or resterilize.
Potential Adverse Effects
The Potential Complications, which may result from a ureteral stent procedure, include ureteral reflux, extravasation, cathter occlusion, catheter dislodgment, hemorrhage, sepsis, perforation of the urinary tract, and peritonitis. Products with HydroPlus Coating may cause slight irritation in some individuals.
Cautions
NOTE: Where long-term use is indicated, it is recommended that indwelling time not exceed 365 days. This stent should be evaluated by the physician on or before 90 days postplacement.
Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.
Trademark
Percuflex, Contour, Hydro Plus, and Nautilus are trademarks of Boston Scientific Corporation or its affiliates.
Indicated for use for catheterization of the urinary tract during interoperative procedures, including but not limited to ureteral occlusion for injection of contrast medium, delivery of irrigation fluids to the ureter, drainage of fluids from the urinary tract, and access, advancement or exchange of ancillary devices including guidewires.
Contraindications
Contraindicated for patients unsuitable for catheterization.
Warnings
For single use only. Do not reuse, reprocess or resterilize.
Potential Adverse Effects
The Potential Complications may include extravasation, hemorrhage, sepsis, edema, loss of renal function, perforation of kidney, renal pelvis, ureter and bladder, peritonitis, and unrinary tract infection.
Cautions
Indwelling not to exceed 24 hours.
Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.
Trademark
This basket is intended to be used endoscopically to grasp, manipulate and remove calculi from the urinary tract.
Contraindications
• Pregnancy • Renal malignancy • Sepsis • Anticoagulation or bleeding disorders • Presence of very large stones that in the past have failed lithotripsy with basket retrieval
Warnings
• The use of this device should be restricted to use by or under the supervision of physicians trained in urological endoscopic procedures. • Exercise care to prevent perforation or trauma of the linings of the urinary tract and associated tissues. • Some stones may be too large to be removed endoscopically with the stone retrieval basket. Use fluoroscopy or x-ray to determine the size of the stone prior to instrumentation. Do not use the basket if the stone is too large to be removed endoscopically. To do this may result in stone impaction and patient injury. • If resistance is encountered while attempting to withdraw the basket, DO NOT EXERT EXCESSIVE FORCE. • Do not fire the laser directly upon the basket. • If a basket wire is broken during lasing, discontinue lasing immediately. Good surgical procedures should be followed for basket removal. • This basket has no serviceable parts. Do not attempt to repair or alter the device. Do not resterilize the device. Any use of the device other than those indicated is not recommended. • Do not use this basket without the pre-packaged scope adapter. Doing so may result in inability to advance the laser fiber through the working channel of the scope. • This device must not come in contact with any electrified instrument.
Potential Adverse Effects
Potential complications generally recognized with the use of stone retrieval basket devices include, but are not limited to: • Pregnancy • Renal malignancy • Sepsis • Anticoagulation or bleeding disorders • Presence of very large stones that in the past have failed lithotripsy with basket retrieval • Edema • Stone impaction • Entrapment • Stone migration • Evulsion • Urinary frequency • Fever • Urinary tract infection • Hemorrhage • Pain • Ureteral trauma (including stripping, abrasion or perforation There may be other potential adverse events that are unforeseen at this time.
Cautions
PRECAUTION: Before using, inspect the blister pouch for any breach of the package to ensure a sterile product and inspect product for any damage. If seal has been broken or product is damaged. DO NOT USE. Immediately return package and product to your Boston Scientific representative. Kinks in the sheath will hinder the mechanical operation of the basket. It is recommended that the ureter be pre-dilated before endoscopy and stone retrieval to prevent impaction when retracting the stone.
Trademark
SlimLine and SLimLine EZ are trademarks of Lumenis Ltd. Sharplan is a trademark of Laser Industries, Ltd.
The Stone Cone Device is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract.
Contraindications
No contraindications are known.
Warnings
For single use only. Do not reuse, reprocess, or resterilize.
Potential Adverse Effects
The Potential Complications that may result from use of the Stone Cone are perforation, entrapment, evulsion, hemorrhage, edema, stone migration, and stone impaction.
Cautions
Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.
Trademark
Stone Cone is a registered trademark of Med Source Technologies.
The Urological Retrieval Devices are intended to be used during urological procedures to endoscopically grasp, manipulate and remove calculi and other foreign objects.
Contraindications
Some objects may be too large to be removed endoscopically with a retrieval device. To avoid stone impaction, fluoroscopy or x-ray should be used to determine the size of the object; do not use the retrieval device if the object is too large to be removed endoscopically or to be held within the device.
Warnings
For single use only. Do not reuse, reprocess or resterilize. This device must not come in contact with any electrified instrument. This device should not be directly fired upon by a laser or lithotripter; to do so may damage the device and could result in patient injury.
Potential Adverse Effects
The Potential Complications, which may result from a urological retrieval procedure, include perforation, entrapment, evulsion, hemorrhage, and edema.
Cautions
Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physcian.
The Urological Retrieval Devices are intended to be used during urological procedures to endoscopically grasp, manipulate and remove calculi and other foreign objects.
Contraindications
Some objects may be too large to be removed endoscopically with a retrieval device. To avoid stone impaction, fluoroscopy or x-ray should be used to determine the size of the object; do not use the retrieval device if the object is too large to be removed endoscopically or to be held within the device.
Warnings
For single use only. Do not reuse, reprocess or resterilize. This device must not come in contact with any electrified instrument. This device should not be directly fired upon by a laser or lithotripter; to do so may damage the device and could result in patient injury.
Potential Adverse Effects
The potential complications, which may result from a urological retrieval procedure, include perforation, entrapment, evulsion, hemorrhage, and inability to disengage from irretrievable object, edema, and basket inversion.
Cautions
Before using, inspect the sterile barrier for any breach of the package to ensure a sterile product and inspect product for any damage. If seal has been broken or product is damaged DO NOT USE. Immediately return package and product to Boston Scientific. If resistance is encountered during advancement or withdrawal of device, DO NOT EXERT EXCESSIVE FORCE.
Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.
The Ureteral Stent is intended to facilitate drainage from the kidney to the bladder.
Contraindications
Contraindicated for poor surgical risk patients, unexplained hematuria and un-repaired ureteral avulsion.
Warnings
For single use only. Do not reuse, reprocess or resterilize.
Potential Adverse Effects
The Potential Complications, which may result from a ureteral stent procedure, include ureteral reflex, extravasation, stent occlusion, dislodgment, hemorrhage, sepsis, perforation of the urinary tract, and peritonitis.
Cautions
Federal (USA) law restricts these devices to sale by or on the order of a physician.
The double pigtail Percuflex® ureteral stents are intended to facilitate drainage from the kidney to the bladder via placement endoscopically or fluoroscopically or during an open surgical procedure by a trained physician.
Contraindications
The double pigtail Percuflex ureteral stents are contraindicated for use with the following procedures and/or conditions:
Warnings
For single use only. Do not reuse, reprocess, or resterilize.
Potential Adverse Effects
Potential complications associated with retrograde and antegrade positionedindwelling ureteral stents:
Cautions
Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.
The Boston Scientific Urological Guidewires are intended to facilitate the placement of endourological instruments during diagnostic or interventional procedures.
Contraindications
No contraindications are known.
Warnings
For single use only. Do not reuse, reprocess or resterilize. Do not manipulate, advance and/or withdraw the guidewire through a metal cannula or needle; to do so may result in destruction and/or separation of the device, which may result in injury. Do not use a retrieval device while the guidewire is in place; to do so may cause damage to the guidewire.
Potential Adverse Effects
The Potential Complications, which may result from use of a guidewire in urological guidewire procedures, include perforation of the urinary tract, hemorrhage, edema, acute bleeding and tissue trauma.
Cautions
Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.
The Urological Retrieval Devices are intended to be used during urological procedures to endoscopically grasp, manipulate and remove calculi and other foreign objects.
Contraindications
Some objects may be too large to be removed endoscopically with a retrieval device. To avoid stone impaction, fluoroscopy or x-ray should be used to determine the size of the object; do not use the retrieval device if the object is too large to be removed endoscopically or to be held within the device.
Warnings
For single use only. Do not reuse, reprocess or resterilize. This device must not come in contact with any electrified instrument. This device should not be directly fired upon by a laser or lithotripter; to do so may damage the device and could result in patient injury.
Potential Adverse Effects
The Potential Complications, which may result from a urological retrieval procedure, include perforation, entrapment, evulsion, hemorrhage, and inability to disengage from irretrievable object, edema, and basket inversion.
Cautions
Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.
Trademark
ZeroTip is a trademark of Boston Scientific Corporation or its affiliates.
The Urological Guidewires are intended to facilitate the placement of endourological instruments during diagnostic or interventional procedures.
Contraindications
No contraindications are known.
Warnings
For single use only. Do not reuse, reprocess or resterilize. Do not manipulate, advance and/or withdraw the guidewire through a metal cannula or needle; to do so may result in destruction and/or separation of the device, which may result in injury. A retrieving device, such as a gripper or basket forceps, should only be used after the guidewire has been removed from the patient's channel or duct. Using a retrieving device while the guidewire is in place may cause the guidewire to break.
Potential Adverse Effects
The Potential Complications, which may result from use of a guidewire in urological guidewire procedures, may include perforation of the urinary tract, hemorrhage, edema, acute bleeding, and tissue trauma.
Cautions
Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.
The Urological Balloon Dilatation Catheter is intended to dilate strictures of the urinary tract.
Contraindications
This product is contraindicated in the presence of conditions which create unacceptable risk during catheterization.
Warnings
For single use only. Do not reuse, reprocess or resterilize.
Potential Adverse Effects
The Potential Complications, which may result from a balloon dilatation procedure, include tissue trauma and tissue perforation.
Cautions
If resistance is encountered during advancement or withdrawal of device, DO NOT EXERT EXCESSIVE FORCE. Do not inflate balloon dilatation catheter while balloon is directly beside the stone. Refer to package label for balloon's rated burst pressure.
Federal (USA) law and governing law outside USA restricts these devices to sale by or on the order of a physician.
For products with HydroPlus™ Coating: refer to package insert for instructions on preparing the product for use. Care should be exercised if passing a HydroPlus coated balloon through any metal containing systems. Do not wrap gauze around the balloon. Minimize excessive handling. Do not wipe balloon with dry gauze or gauze wet with any solvent other than sterile water or saline.
Intended to facilitate the drainage of urine from the kidney to the bladder.
Contraindications
Contraindicated for use in patients with poor surgical risk, unexplained hematuria, or unrepaired ureteral avulsion.
Warnings
For single use only. Do not reuse, reprocess, or resterilize.
Potential Adverse Effects
The Potential Complications associated with a retrograde or antegrade positioned indwelling ureteral stents may include pain, ureteral reflux, extravasation, catheter occlusion, catheter dislodgment, hemorrhage, sepsis, perforation, and peritonitis.
Cautions
Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.
Trademark
Stretch VL and Flexima are trademarks of Boston Scientific Corporation or its affiliates.
The Urological Guidewires are intended to facilitate the placement of endourological instruments during diagnostic or interventional procedures.
Contraindications
No contraindications are known.
Warnings
For single use only. Do not reuse, reprocess, or resterilize. Do not manipulate, advance and/or withdraw the guidewire through a metal cannula or needle; doing so may result in destruction and/or separation of the device, which may result in injury. Do not use a retrieval device while the guidewire is in place; doing so may cause damage to the guidewire.
Potential Adverse Effects
The Potential Complications, which may result from use of a guidewire in urological guidewire procedures, may include, but are not limited to: perforation of the urinary tract, hemorrhage, edema, acute bleeding, and tissue trauma.
Cautions
Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.
The Swiss LithoClast Ultra is intended for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.
Contraindications
Contraindicated in patients with active bleeding disorders, solitary functioning kidney, creatinine greater than or equal to 3 mgm percent, during pregnancy, under the age of 18, stricture and obstruction problems, and with electrical stimulator implanted e.g. pacemaker.
Warnings
For single use only. Do not reuse, reprocess, or resterilize.
Potential Adverse Effects
The Potential Complications from use of the Swiss LithoClast Ultra may include, but are not limited to, perforation, hemorrhage, lesion, stone migration, pain/colic, macroscopic hematuria, infection, and ureteral obstruction.
Cautions
Federal (USA) law and governing law outside the USA restricts this device to sale by or on the order of a physician.
Trademark
Swiss LithoClast is a registered trademark of Ferton Holding SA
Federal (USA) law and governing law outside the USA restricts these devices to sales by or on the order of a physician.
Swiss LithoClast Ultra is manufactured by EMS Electro Medical Systems S.A. and distributed in the U.S. exclusively by Boston Scientific Corporation.
The Guidewires are intended to facilitate the placement of endourological instruments during diagnostic or interventional procedures.
Contraindications
No contraindications are known.
Warnings
For single use only. Do not reuse, reprocess or resterilize. Do not manipulate, advance and/or withdraw the guidewire through a metal cannula or needle; to do so may result in destruction and/or separation of the device, which may result in injury. Do not use a retrieval device while the guidewire is in place; to do so may cause damage to the guidewire.
Potential Adverse Effects
The Potential Complications, which may result from the use of a guidewire in urological guidewire procedures, include perforation of the urinary tract, hemorrhage, edema, acute bleeding, and tissue trauma.
Cautions
Before using, inspect the sterile barrier for any breach of the package to ensure a sterile product and inspect product for any damage. If seal has been broken or product is damaged DO NOT USE. Immediately return package and product to Boston Scientific. If resistance is encountered during advancement or withdrawal of device, DO NOT EXERT EXCESSIVE FORCE. Do not use the guidewire if it becomes damaged to do so will prevent accurate torque or tactile response and may cause injury.
Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.
Trademark
Glidewire is a registered trademark of Terumo Corporation.
The Urological Retrieval Devices are intended to be used during urological procedures to endoscopically grasp, manipulate and remove calculi and other foreign objects.
Contraindications
Some objects may be too large to be removed endoscopically with a retrieval device. To avoid stone impaction, fluoroscopy or x-ray should be used to determine the size of the object; do not use the retrieval device if the object is too large to be removed endoscopically or to be held within the device.
Warnings
For single patient use only. Do not reuse, reprocess or resterilize. This device must not come in contact with any electrified instrument. This device should not be directly fired upon by a laser or lithotripter; to do so may damage the device and could result in patient injury.
Potential Adverse Effects
The potential complications, which may result from a urological retrieval procedure, include perforation, entrapment, evulsion, hemorrhage, inability to disengage from irretrievable object, edema, and basket inversion.
Cautions
Before using, inspect the sterile barrier for any breach of the package to ensure a sterile product and inspect product for any damage. If seal has been broken or product is damaged DO NOT USE. Immediately return package and product to Boston Scientific. If resistance is encountered during advancement or withdrawal of device, DO NOT EXERT EXCESSIVE FORCE.
Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.
The Polaris Loop Ureteral Stents are intended to facilitate drainage from the kidney to the bladder via placement endoscopically, fluoroscopically, or during an open surgical procedure by a trained physician.
Contraindications
The Polaris Loop Ureteral Stents are contraindicated for use with the following procedures and/or conditions:
Warnings
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found call your Boston Scientific representative. For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
Potential Adverse Effects
Potential complications associated with retrograde positioned indwelling ureteral stents:
Cautions
*Data on file at Boston Scientific for a 236 subject clinical trial at 13 investigation sites located throughout USA and Canada.
The Navigator Ureteral Access Sheath is indicated for use in endocsopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
Contraindications
Patients who are contraindicted for Retrograde urologic procedures; Presence of tight strictures which would limit use of the device; Presence of large obstructing distal ureteral stone.
Warnings
The recommendations given are meant to serve only as a basic guide to the utilization of this access sheath set. The ureteral sheath set should not be used without comprehensive knowledge of the indications, techniques and risks of the procedure.
To minimize resistance during advancement, ensure the hydrophilic coating on the dilator and sheath is activated with saline or sterile water prior to placement.
Potential Adverse Effects
Potential complications associated with the use of the transurethral access device include, but not limited to: mucosal irritation, inflammation and edema; uretheral strictures; acute bleeding or hemorrhage; urethral, bladder, or ureteral perforation; other injury to the urinary tract.
Cautions
To minimize resistance during advancement, ensure the hydrophilic coating on the dilator and sheath is activated with saline or sterile water prior to placement. DO NOT bend or kink the catheter prior to placement, to do so could damage the integrity of the catheter and result in patient injury. If resistance is encountered during advancement or withdrawal of the catheter, STOP. DO NOT continue without the dilator in place, to do so could cause injury to the patient. Caution: Federal law (U.S.A) restricts this device to sale, distribution and use by or on the order of a physician. Refer to the Directions for Use provided with this product for complete instructions, warnings, and precautions prior to using this product.
The Urological Retrieval Device is intended to be used during urological procedures to endoscopically grasp, manipulate and remove calculi and other foreign objects.
Contraindications
Some objects may be too large to be removed endoscopically with a retrieval device. To avoid stone impaction, fluoroscopy or x-ray should be used to determine the size of the object; do not use the retrieval device if the object is too large to be removed endoscopically or to be held within the device.
Warnings
For single use only. Do not reuse, reprocess or resterilize. This device must not come in contact with any electrified instrument. This device should not be directly fired upon by laser or lithotripter; to do so may damage the device and could result in patient injury.
Potential Adverse Effects
The Potential Complications, which may result from a urological retrieval procedure, include perforation, entrapment, evulsion, hemorrhage, and edema.
Cautions
Federal (USA) law and governing law outside the USA restricts the sale by or on the order of a physician.