FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING

Additional Manufacturer Narrative

D2A - COMMON DEVICE NAME: BILIARY CATHETER FOR STONE REMOVAL THAT MAY ALSO ALLOW FOR IRRIGATION AND CONTRAST INJECTION. E1 - COUNTRY: FRENCH POLYNESIA. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PHOTOS PROVIDED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. PER THE PHOTOS PROVIDED WE CANNOT COMPLETE A FULL EVALUATION. WITHOUT THE PRODUCT OR SUBSTANTIAL EVIDENCE TO CONTRADICT THE COMPLAINT, IT IS CONSIDERED CONFIRMED BASED SOLELY ON STATEMENTS AND PHOTOS DESCRIBING THE EVENT. THE FIRST PHOTO SHOWS THE BALLOON INFLATED; HOWEVER THE STOP COCK AND SYRINGE CANNOT BE SEEN IN THE PHOTO TO DETERMINE IF THE BALLOON IS STUCK IN THE INFLATED POSITION. THE SECOND PHOTO SHOWS THE BALLOON ALMOST INFLATED, WITH A MINIMAL AMOUNT OF AIR LEFT IN THE BALLOON. THE THIRD PHOTO SHOWS THE DEVICE, AND THE BALLOON HAS FULLY DEFLATED. 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: OUR EVALUATION OF THE PHOTOS PROVIDED CONFIRMED THE REPORT AND WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. HOWEVER, IT CAN ALSO BE CONFIRMED BASED ON USER'S ALLEGING THAT THE DEVICE WOULD DEFLATE OVER TIME, JUST TAKING MUCH MORE DIFFICULTY THAN EXPECTED. PRIOR TO DISTRIBUTION, ALL FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING ARE SUBJECTED TO A VISUAL AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. THE FUNCTIONAL TEST INCLUDES AN AIR INFLATION TEST TO ENSURE PROPER BALLOON FUNCTION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

Description of Event or Problem

IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. IT WAS REPORTED [THAT] THE BALLOON INFLATED NORMALLY, BUT IT WAS IMPOSSIBLE TO DEFLATE IT DESPITE SEVERAL ATTEMPTS BY DIFFERENT STAFF MEMBERS (NURSES AND PHYSICIANS). THE BALLOON REMAINED INFLATED AND VERY HARD. FINALLY, AFTER AN HOUR, THE NURSE TRIED AGAIN TO DEFLATE IT, AND THIS TIME IT WORKED. IT WAS TAKEN DEFLATED TO THE PHARMACY, AND THE PROBLEM WAS NO LONGER OBSERVED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.