Escape® Nitinol Stone Retrieval Basket

Prescriptive Information

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.