FUSION QUATTRO EXTRACTION BALLOON

Additional Manufacturer Narrative

CONTINUED D2A COMMON DEVICE NAME: BILIARY CATHETER FOR STONE REMOVAL THAT MAY ALSO ALLOW FOR IRRIGATION AND CONTRAST INJECTION. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: A CORRECTIVE ACTION (CAPA) HAS BEEN INITIATED TO REDUCE OCCURRENCES OF BALLOON RUPTURES. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTIONS. IN THE INFORMATION PROVIDED IN THE REPORT, IT STATES THE BALLOON WAS TESTED PRIOR TO ADVANCEMENT DOWN THE ENDOSCOPE ACCESSORY CHANNEL AND INFLATED PROPERLY. A PINHOLE, SPLIT, OR RUPTURE IN THE BALLOON CAN OCCUR IF THE BALLOON MATERIAL HAS COME INTO CONTACT WITH A SHARP OBJECT, SUCH AS A SHARP STONE OR POSSIBLY A BURR IN THE ENDOSCOPE CHANNEL. A SPLIT OR RUPTURE IN THE BALLOON MATERIAL CAN ALSO OCCUR IF ADDED PRESSURE WAS APPLIED DURING EXTRACTION. THE INSTRUCTIONS FOR USE DIRECT THE USER TO "GENTLY WITHDRAW THE INFLATED BALLOON TOWARD THE PAPILLA." THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING: ¿WARNING: DO NOT EXERT EXCESSIVE PRESSURE ON AMPULLA WHILE EXTRACTING STONES. IF STONE DOES NOT PASS EASILY, REASSESS NEED FOR SPHINCTEROTOMY.¿ PRIOR TO DISTRIBUTION, ALL FUSION QUATTRO EXTRACTION BALLOON ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A CORRECTIVE ACTION (CAPA) HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

Description of Event or Problem

DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY [ERCP], THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED [THAT] THE BALLOON COULD BE HEARD AUDIBLY POPPING ON FIRST ATTEMPT TO TRAWL STONES. INITIALLY THIS WAS PUT DOWN TO A SHARP STONE BEING TRAWLED BUT ON INSPECTION IT APPEARED THERE IS NO BALLOON REMAINING ATTACHED TO THE CATHETER [SUBJECT OF REPORT]. THE DETACHED BALLOON MATERIAL REMAINED INSIDE THE PATIENT¿S BODY TO PASS NATURALLY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.