FUSION QUATTRO EXTRACTION BALLOON

Description of Event or Problem

IN PREPARATION FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE USER SELECTED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED \[THAT]" THE USER INFLATED THE BALLOON BEFORE USE FOR CHECKING BUT FOUND THE BALLOON CANNOT BE RETRACTED \[UNABLE TO DEFLATE]", \[SO]" USER REMOVED THE 3 WAY VALVE AND STILL COULDN'T RETRACT THE BALLOON AFTER MULTIPLE ATTEMPTS. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

Additional Manufacturer Narrative

INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE VIDEOS PROVIDED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. PER THE VIDEOS 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 VIDEOS DESCRIBING THE EVENT. THE FIRST VIDEO SHOWS THAT THERE IS NO SYRINGE OR STOPCOCK ATTACHED TO THE INFLATION PORT, AND THE BALLOON IS REMAINING INFLATED. THE SECOND VIDEO SHOWS THE SYRINGE AND STOPCOCK ATTACHED TO THE INFLATION PORT, THE STOPCOCK IS IN THE OPEN POSITION, AND NEGATIVE PRESSURE IS BEING APPLIED TO THE SYRINGE, BUT THE BALLOON IS REMAINING INFLATED. THE THIRD VIDEO SHOWS THE SYRINGE AND STOPCOCK ATTACHED TO THE INFLATION PORT, AND WHEN THE SYRINGE AND STOPCOCK ARE BOTH REMOVED FROM THE INFLATION PORT, THE BALLOON IS REMAINING INFLATED. 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 VIDEOS PROVIDED CONFIRMED THE REPORT; HOWEVER, WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL FUSION QUATTRO EXTRACTION BALLOON 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.