FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING

Additional Manufacturer Narrative

CONTINUED D2A COMMON DEVICE NAME: 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 A CLEAR PLASTIC BAG WITH AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED. THE BALLOON INFLATED AND DEFLATED WITHOUT DIFFICULTY. THE DEVICE WAS RETURNED IN A COILED POSITION WITH THE SYRINGE STILL ATTACHED TO THE INFLATION PORT. THE BALLOON WAS INFLATED WITH AIR USING THE SYRINGE PROVIDED. THE BALLOON INFLATED AS EXPECTED AND THE STOP COCK WAS TURNED TO CLOSED. A VISUAL EXAMINATION OF THE BALLOON DID NOT FIND ANY LEAKS OR DEFECTS. UPON TURNING THE STOPCOCK TO OPEN, THE BALLOON DEFLATED WITHIN A FEW SECONDS (REFERENCE ATTACHED INFLATION/DEFLATION VIDEO). NO OTHER ANOMALIES WERE DETECTED WITH THE DEVICE. 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 LABORATORY EVALUATION OF THE RETURNED DEVICE COULD NOT CONFIRM THE REPORT, THE BALLOON INFLATED AND DEFLATED WITHOUT DIFFICULTY. A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL PRIOR TO USE TESTING CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. 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 BILE DUCT STONE REMOVAL PROCEDURE, THE USER SELECTED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. IT WAS REPORTED THAT DURING PREPARATION, THE BALLOON WAS OBSERVED TO BE UNABLE TO DEFLATE, AND THE DEVICE WAS NOT USED. THE PROCEDURE WAS COMPLETED USING A NEW COOK FS-8.5-12-15-B DEVICE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

Additional Manufacturer Narrative

CONTINUED: D2A COMMON DEVICE NAME: BILIARY CATHETER FOR STONE REMOVAL THAT MAY ALSO ALLOW FOR IRRIGATION AND CONTRAST INJECTION. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.