BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA BILIARY STENT SYSTEM

    MDR report key: 1193270 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05110
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 11, 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, THE DEVICE HAD DIFFICULTY ADVANCING AND RETRACTING FROM THE SCOPE. A BILIARY STENT 8.5FR/10CM HAD BEEN SELECTED TO TREAT AN UNSPECIFIED BILIARY LESION. THE PHYSICIAN INITIALLY ENCOUNTERED RESISTANCE IN ADVANCING THE DEVICE THROUGH THE NON-BSC SCOPE, BUT EVENTUALLY WAS ABLE TO ADEQUATELY ADVANCE THE DEVICE TO THE TARGET LESION AND DEPLOY THE STENT. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE OUTER SHEATH, BUT THE MARKER ON THE OUTER SHEATH BECAME STUCK ON THE SCOPE TIP. THE PHYSICIAN REMOVED THE STENT DELIVERY SYSTEM AND SCOPE FROM THE PATIENT AS A UNIT. THE PHYSICIAN CUT THE TIP OF THE DELIVERY SYSTEM AND THE CATHETER WAS ABLE TO BE SEPARATED FROM THE SCOPE. THE MARKER REMAINED ON THE OUTER SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'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 M00539260 11830954

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS JF260