FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING

Description of Event or Problem

DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR BILE DUCT STONE REMOVAL, THE PHYSICIAN USED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. IT WAS INITIALLY REPORTED THAT THE USER ADVANCED THE DEVICE TO DESIRED POSITION AND UTILIZED THE SYRINGE FROM THE PACKAGE TO INFLATE THE BALLOON AND DISCOVERED THAT THE BALLOON SHRUNK DUE TO SUSPECTED THE LEAKING ISSUE. THE USER CHANGED TO A NEW BALLOON TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RECEIVED AND EVALUATED ON 09JUN2026 AND IT WAS NOTED THAT THERE WERE PARTS OF THE BALLOON MATERIAL MISSING [SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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.

Additional Manufacturer Narrative

CONTINUED: D2A: BILIARY CATHETER FOR STONE REMOVAL THAT MAY ALSO ALLOW FOR IRRIGATION AND CONTRAST INJECTION. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN AN OPEN BOX FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE WAS RETURNED WITH THE SYRINGE STILL ATTACHED TO THE INFLATION PORT, AND THE BALLOON RUPTURED. UNDER MAGNIFICATION, IT WAS IDENTIFIED THERE WAS A PORTION WHERE THE BALLOON MATERIAL DID NOT MATCH UP AND A PORTION APPEARS TO BE MISSING. THE MISSING PORTION OF THE BALLOON WAS NOT RETURNED WITH THE DEVICE. NO OTHER ANOMALIES WERE DETECTED WITH THE DEVICE. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. NONCONFORMANCES THAT COULD POTENTIALLY BE RELATED TO THE COMPLAINT WERE CONTAINED IN THE ASSOCIATED DHR. THE NONCONFORMANCE DOCUMENTATION SUPPORTS THE AFFECTED DEVICE(S) WERE DISPOSITIONED APPROPRIATELY PRIOR TO RELEASE OF THIS LOT. THERE IS NO EVIDENCE NONCONFORMING PRODUCT WAS RELEASED FOR DISTRIBUTION. IN AN EFFORT TO HEIGHTEN AWARENESS OF THE POTENTIAL CONNECTION OF THE CUSTOMERS REPORT TO THE CURRENT MANUFACTURING PROCESSES PRODUCTION PERSONNEL WERE NOTIFIED. INVESTIGATION CONCLUSION: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. 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. BASED ON THE INFORMATION PROVIDED IN THE REPORT, THE BALLOON WAS INFLATED PRIOR TO USE AND INFLATED PROPERLY. THIS MEANS THE BALLOON WAS INTACT AND FUNCTIONING PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE ACCESSORY CHANNEL. 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 EXTRACTION BALLOON WITH MULTIPLE SIZING 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.