BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT

    MDR report key: 1063634 · Received June 19, 2008

    Report

    Report Number
    3005099803-2008-00769
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K956147
    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, THE RO MARKER BAND DISLODGED INSIDE THE PATIENT. AN 8.5 FR/7CM FLEXIMA BILIARY STENT HAD BEEN IMPLANTED TO TREAT AN UNSPECIFIED LESION. WHILE ATTEMPTING TO REMOVE THE STENT DELIVERY SYSTEM, RESISTANCE WAS NOTED. IT WAS DISCOVERED THAT THE RO MARKER BAND HAD DETACHED FROM THE OUTER SHEATH AND WAS LODGED IN THE DUODENUM. THE DETACHED PORTION REMAINS IN THE PT. THE PHYSICIAN "IS NOT PLANNING TO RETRIEVE" THE DETACHED RO MARKER. 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 BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC 11609693

    Patients

    Seq Age Sex Outcome Treatment
    1