BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA BILIARY STENT SYSTEM

    MDR report key: 1231064 · Received October 30, 2008

    Report

    Report Number
    3005099803-2008-05547
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    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 TREATMENT PROCEDURE, DEPLOYMENT DIFFICULTIES WERE ENCOUNTERED AND THE STENT WAS DEPLOYED INSIDE THE SCOPE. A BILIARY STENT 7FR/15CM HAD BEEN SELECTED TO TREAT AN UNSPECIFIED STENOSIS IN THE BILE DUCT. THE PHYSICIAN FOUND IT "VERY DIFFICULT" TO CROSS THE LESION WITH THE DEVICE BUT WAS EVENTUALLY ABLE TO CROSS THE LESION. WHILE ATTEMPTING TO DEPLOY THE DEVICE, "SEVERE" RESISTANCE WAS ENCOUNTERED. THE DEVICE MOVED FROM ITS INTENDED TARGET AND WAS DEPLOYED INSIDE THE SCOPE. THE STENT WAS ABLE TO BE REMOVED FROM THE PT WITH THE REMOVAL OF THE SCOPE. THE PROCEDURE WAS ABORTED WITH THE PHYSICIAN INTENDING TO PERFORM BALLOON DILATION AND STENTING "LATER". THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC M00539240 11508435

    Patients

    Seq Age Sex Outcome Treatment
    1