BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT BILIARY ENDOPROSTHESIS

    MDR report key: 1161304 · Received September 11, 2008

    Report

    Report Number
    3005099803-2008-04489
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    911292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BILIARY STENTING TREATMENT PROCEDURE, THE HANDLE DETACHED. THE TARGET LESION WAS IN THE COMMON BILE DUCT (CBD). A 8FR 10X80 194CM WALLSTENT BILIARY HAD BEEN ADVANCED TO THE TARGET LESION. DURING DEPLOYMENT, WITH THE UNSPECIFIED TYPE TO SCOPE "IN LONG POSITION AND CURVED", RESISTANCE WAS ENCOUNTERED AND THE "TRANSPARENT PART DETACHED FROM THE BLUE CATHETER". THE STENT WAS UNABLE TO BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC H965431200 8855209

    Patients

    Seq Age Sex Outcome Treatment
    1