BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEENEN PANCREATIC STENT SET

    MDR report key: 1895335 · Received November 2, 2010

    Report

    Report Number
    3001845648-2010-00020
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 6, 2010
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K900923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO GEPD-7-7 DEVICES OF LOT NUMBER C574002 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. ONE X GEPD-7-7 WAS RETURNED TO COOK (B)(4) FOR INVESTIGATION. THE PROXIMAL END WITH ITS 2 FLAPS AND THE DISTAL END WITH ITS 2 FLAPS WERE NOT RETURNED WITH THE STENT. THE SECTION OF THE STENT THAT WAS RETURNED WAS NOTED TO BE BLACKENED. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE STENT WAS BROKEN ON EVAL. THE BLACKENING OF THE STENT WAS MOST LIKELY DUE TO PANCREATIC FLUID AS THE SCHEDULED STENT REMOVAL WAS DUE TO THE STENT BEING PARTIALLY OCCLUDED AND WAS IN THE PANCREATIC DUCT. PRIOR TO DISTRIBUTION, GEENEN PANCREATIC STENTS ARE SUBJECTED TO VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MFG RECORDS FOR THE GEPD-7-7 DEVICE INVOLVED IN THIS COMPLAINT REPORT DID NOT REVEAL ANY DISCREPANCIES, WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. A REVIEW OF THE 2-YR COMPLAINTS HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. THIS TYPE OF REPORT REPRESENTS AN UNUSUAL OCCURRENCE. BASED ON THE REVIEW, THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. COMPLAINTS OF THIS NATURE WILL BE MONITORED FOR POTENTIAL EMERGING TRENDS. 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 PT ANATOMY OR PROGRESSION OF DISEASE STATE, COOK (B)(4) COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF DEVICE USAGE.

    Description of Event or Problem · 1

    THE PT WAS SUFFERING FROM AMPULLARY ADENOMA, CHRONIC PANCREATITIS, PRIOR TO STENT PLACEMENT. THE STENT WAS IN PLACE FOR APPROX 1 MONTH. IT IS UNDERSTOOD THAT THE STENT FUNCTIONED AS INTENDED UNTIL IT WAS DETERMINED THAT THE STENT WAS PARTIALLY OCCLUDED WHICH LED TO THE SCHEDULED STENT REMOVAL DUE TO THE STENT BEING PARTIALLY OCCLUDED. WHEN REMOVAL OF THE STENT WAS BEING CARRIED OUT, THE STENT BROKE. THE PT WAS SCHEDULED TO HAVE THE REMAINING SECTION OF THE STENT REMOVED 2 WEEKS AFTER THIS INCIDENT. TO-DATE, THE SECTION OF THE STENT HAS NOT BEEN REMOVED. NO PROBLEMS, STANDARD PRACTICE PROCEDURE. THE PT WAS SENT HOME AND ASKED TO RETURN 1 MONTH LATER TO REMOVE THE REMAINDER OF THE STENT - BASED ON THIS INFO, IT IS BELIEVED THAT THE PT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEENEN PANCREATIC STENT SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C574002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention