NephroMax™ High Pressure Nephrostomy Balloon Catheter

Prescriptive Information

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.