BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEENEN PANCREATIC STENT

    MDR report key: 3946829 · Received July 9, 2014

    Report

    Report Number
    3001845648-2014-00126
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 10, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K900923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO GPS0-5-7 (GEENEN STENT) DEVICES OF LOT# C962850 REMAINING IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. ONE X GPS0-5-7 DEVIDE OF LOT NUMBER C962850 WAS RETURNED TO COOK IRELAND FOR EVALUATION. THE DEVICE WAS RETURNED IN IT'S ORIGINAL PACKAGE. ONLY ONE PART OF THE STENT WAS RETURNED. THE LENGTH OF THE RETURNED PART MEASURED APPROXIMATELY 3CM. UPON EVALUATION IT WAS OBSEIVED THAT THE STENT WAS DAMAGED AT ONE END. THIS IS MOST LIKELY AS A RESULT OF THE SNARE USED DURING REMOVAL OF THE STENT . THE OTHER END OF THE RETURNED PART OF THE STENT WAS BROKEN AT THE FLAP. IT WAS EVIDENT THAT IT HAD BEEN CUT. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE RETURNED PART OF THE STENT WAS BROKEN. AS THE CONDITIONS OF USE 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 STENTS ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN THE PROCEDURES REFERENCED ABOVE AND ATTACHED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE GEENEN STENT INVOLVED IN THIS COMPLAINT DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT ISSUE. THIS DEVICE IS USED TO DRAIN OBSTRUCTED PANCREATIC DUCTS. ACCORDING TO THE INSTRUCTIONS FOR USE THE USER IS ADVISED AS FOLLOWS: "IF THE PACKAGE IS OPENED OR DAMAGED WHEN RECEIVED, DO NOT USE. VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". THE PRECAUTION SECTION OF THE IFU STATES THAT "THIS DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN. PERIODIC EVALUATION IS RECOMMENDED". AN ADDITIONAL SURGERY HAS BEEN SCHEDULED FOR THE REMAINING PIECE OF THE STENT TO BE REMOVED FROM THE PATIENT. NO FURTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE STENT WAS ALREADY IN THE PT. THE STENT WAS INTENTIONALLY CUT WHEN THE "APULECTOMY" WAS PERFORMED. WHEN TRYING TO REMOVE THE STENT IT WAS GRABBED WITH A SNARE. AS THEY WERE PULLING THE STENT OUT WITH THE SNARE, THE STENT BROKE. THEY TRIED AGAIN TO PULL OUT THE REMAINING PART OF THE STENT AND IT BROKE AGAIN. A PART OF THE BROKEN STENT REMAINED INSIDE THE PT'S PANCREATIC DUCT. ANOTHER PANCREATIC STENT WAS PLACED TO FINISH THE CASE. A SECTION OF THE STENT DID REMAIN INSIDE THE PT'S BODY. AN ADD'L PROCEDURE HAS BEEN SCHEDULED TO REMOVE THE REMAINING PIECE OF STENT FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399076 GEENEN PANCREATIC STENT CATHETER, BILIARY, DIAGNOSTIC, FGE COOK IRELAND LTD C962850

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention