MEMORY HARD WIRE BASKET

Description of Event or Problem

DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN SELECTED TWO COOK MEMORY HARD WIRE BASKETS. IT WAS REPORTED THAT THE USER OPENED THE PACKAGE AND FOUND OUT THE BASKET RETRACTION INTO THE SHEATH WAS DIFFICULT, WITH SLIGHTLY ADDITIONAL FORCE THE SHEATH KINK.THIS OCCURRED DURING A PRODUCT DEMONSTRATION; NO PATIENT WAS INVOLVED.

Additional Manufacturer Narrative

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: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.A CORRECTIVE ACTION (CAPA) HAS BEEN INITIATED TO ADDRESS INSTANCES OF DIFFICULTY DURING BASKET ADVANCEMENT AND RETRACTION. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTIONS.PRIOR TO DISTRIBUTION, ALL MEMORY HARD WIRE BASKETS 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. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTION. THIS OBSERVATION OCCURRED PRIOR TO USE. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.