BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEENEN PANCREATIC STENT

    MDR report key: 1980169 · Received January 31, 2011

    Report

    Report Number
    3001845648-2011-00003
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K900923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THE DEVICE INVOLVED IN THIS COMPLAINT IS AVAILABLE FOR EVALUATION BUT TO-DATE, IT HAS NOT BEEN RECEIVED AT COOK (B)(4) (THE MANUFACTURER). A PHOTO OF THE STENT WAS RECEIVED AND A VISUAL EVALUATION WAS CARRIED OUT BASED ON THE PHOTOGRAPH. A DETAILED EVALUATION WILL BE CARRIED OUT WHEN THE DEVICE IS RECEIVED AT THE MANUFACTURER SITE. THE ACTUAL LOT NUMBER OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED. AS THE LOT NUMBER WAS NOT PROVIDED; IT WAS THEREFORE, NOT POSSIBLE TO ESTABLISH IF THERE WERE ANY DEVICES FROM THE AFFECTED LOT NUMBER IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE DEVICE INVOLVED IN THIS COMPLAINT IS AVAILABLE FOR EVALUATION, BUT TO-DATE, IT HAS NOT BEEN RECEIVED AT COOK (B)(4). A PHOTO OF THE STENT WAS RECEIVED FROM COOK ENDOSCOPY. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE STENT WAS BROKEN ON EVALUATION OF THE PHOTOGRAPH PROVIDED BY COOK ENDOSCOPY. IT HAS BEEN CONFIRMED THAT ALL SECTIONS OF THE STENT WERE SUCCESSFULLY REMOVED FROM THE PATIENT. AS ACTUAL USE CONDITIONS COULD NOT BE REPLICATED IN THE LABORATORY SETTING AND DUE TO CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY AND PROGRESSION OF DISEASE, THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. PRIOR TO DISTRIBUTION, GEENEN PANCREATIC STENTS ARE SUBJECTED TO VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR THE (B)(4) DEVICE INVOLVED IN THIS COMPLAINT COULD NOT BE REVIEWED AS THE LOT NUMBER COULD NOT BE PROVIDED. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A DEFINITIVE CAUSE FOR THIS OBSERVATION WAS UNABLE TO BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY OR PROGRESSION OF DISEASE STATE, COOK (B)(4) COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF DEVICE USAGE. HOWEVER, CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    THE STENT ORIGINATING IN THE PANCREATIC DUCT WAS EMERGING FROM THE MAJOR PAPILLA. THE STENT WAS SNARED, BUT WHEN TRACTION WAS APPLIED, THE DISTAL MOST 1CM PORTION OF THE STENT FRACTURED OFF. THIS WAS REMOVED. THE STENT WAS AGAIN SNARED IN THE DUODENAL LUMEN. WHEN TRACTION WAS AGAIN APPLIED, THE STENT FRACTURED INSIDE THE PANCREATIC DUCT - A 15-20MM PORTION OF STENT WAS REMAINING IN THE PANCREATIC DUCT IN THE BODY OF THE PANCREAS. EVENTUALLY THE STENT WAS REMOVED WHEN A 9-12MM BALLOON WAS SUCCESSFULLY MANEUVERED UPSTREAM OF THE FRAGMENT. NO STENT FRAGMENTS REMAINED INSIDE THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEENEN PANCREATIC STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention