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Percutaneous Nephrolithotomy (PCNL)
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 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 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 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 Imager II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material.
Contraindications
This device is, in general, contraindicated for use in patients who are unsuitable for ureteral catheterization or the infusion of contrast material.
Warnings
For single use only. Do not reuse, reprocess or resterilize.
Potential Adverse Effects
The potential adverse effects, which may result from ureteral catheter placement may include, but are not limited to: extravasation; hemorrhage; sepsis; edema; loss of renal function; perforation of kidney, renal pelvis, ureter and bladder; peritonitis; and urinary tract infection.
Cautions
Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.
Trademark
Pebax is a trademark of Atochem 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 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 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 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 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.
Indicated for dilatation of the nephrostomy tract.
Contraindications
Contraindicated in the presence of conditions which create unacceptable risk during catheterization.
Warnings
For single patient use only. Do not reuse, reprocess or resterilize.
Potential Adverse Effects
The Potential Complications which may result from a balloon dilatation procedure may include, but are not limited to tissue trauma, tissue perforation, mucosal trauma, urethral perforations, tissue disruption, bleeding, infection, creation of false passages, inability to void, scar tissue formation, and procedural problems due to muscle spasms.
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 Urology. If resistance is encountered during advancement or withdrawal of device, DO NOT EXERT EXCESSIVE FORCE. Refer to package label for balloon's rated burst pressure. Federal (USA) law restricts these devices to sale by or on the order of a physician.
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.
