ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

Description of Event or Problem

As reported, during an arteriogram via pedal access, an Advance 18 LP Low Profile Balloon Catheter's balloon ruptured and separated. A 5-French Cook sheath was used during the procedure. The physician reportedly inflated the balloon to burst pressure within a seventy-percent occluded lesion in the common femoral artery, using an unspecified inflation device; however, the balloon ruptured. It is unknown how many times the balloon was inflated or how long it was inflated prior to rupturing. It is unknown if the balloon ruptured circumferentially or longitudinally, and unknown if it was inflated within a stent. Blood was noted in the inflation device at the time of rupture. The physician then attempted to remove the balloon catheter by itself, at which point the device separated inside of the patient. An arterial cutdown was performed and the separated balloon fragment was retrieved. A section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures or experience any adverse effects due to this event.

Additional Manufacturer Narrative

H3: The device will not be returned to Cook.This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available. This report is required by the FDA under 21 CFR Part 803 and is based on unconfirmed information submitted by others. Neither the submission of this report nor any statement contained herein is intended to be an admission that any Cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any Cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.