BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALL FLEX BILIARY UNCOVERED STENT SYSTEM

    MDR report key: 1990019 · Received February 9, 2011

    Report

    Report Number
    MW5019388
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN THE UNCOVERED STENT WAS IN DUCT, NEEDED TO MOVE POSITION, UNABLE TO RETRACT WIRE. KINKED IN TWO PLACES, PLASTIC STENT INSERTED AS REPLACEMENT. PT STABLE WITH FUNCTIONAL PLASTIC STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALL FLEX BILIARY UNCOVERED STENT SYSTEM NONE FGE BOSTON SCIENTIFIC M00570650 13984017

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention