BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA BILIARY STENT

    MDR report key: 1170149 · Received September 11, 2008

    Report

    Report Number
    3005099803-2008-04477
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Report Date
    August 12, 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 INNER SHEATH OF THE FLEXIMA BILIARY STENT DETACHED. THE LESION WAS LOCATED IN THE COMMON BILE DUCT. THE PHYSICIAN ATTEMPTED TO RETRACT THE INNER SHEATH AND RELEASE THE STENT, BUT FELT RESISTANCE. THE PHYSICIAN CONTINUED TO RETRACT AND THE INNER SHEATH STRETCHED AND DETACHED. THE DETACHED PORTION OF THE SHEATH WAS SUCCESSFULLY REMOVED WITH THE DELIVERY SYSTEM. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO 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 FGE - BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC CORPORATION M00539220 11639279

    Patients

    Seq Age Sex Outcome Treatment
    1