BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA BILIARY STENT SYSTEM

    MDR report key: 1213735 · Received October 22, 2008

    Report

    Report Number
    3005099803-2008-05438
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BILIARY STENTING PROCEDURE, THE STENT WOULD NOT DEPLOY. CANNULATION WAS PERFORMED AND A JAGWIRE WAS INSERTED. AN ENDOSCOPIC SPHINCTEROTOMY WAS PERFORMED AND THE FLEXIMA BILIARY STENT WAS INSERTED INTO THE COMMON BILE DUCT. THE PHYSICIAN ATTEMPTED TO RELEASE THE STENT AND RESISTANCE WAS FELT. THE STENT DELIVERY SYSTEM WAS REPOSITIONED, BUT THE SITUATION DID NOT CHANGE. THE SYSTEM WAS REMOVED FROM THE PATIENT AND COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT WAS REPORTED TO BE "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY STENT SYSTEM FGE - BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC CORPORATION M00539200 11611080

    Patients

    Seq Age Sex Outcome Treatment
    1