BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT BILIARY STENT W/UNISTEP PLUS

    MDR report key: 1193266 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05111
    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
    K982005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON PREPARATION OF THE BARE BILIARY 7.5FR/219CM STENT DELIVERY SYSTEM (SDS), THE PHYSICIAN NOTED THAT THE TIP OF THE STENT HAD RETRACTED INSIDE THE OUTER SHEATH AND WAS UNABLE TO OPEN. THE DEVICE WAS NOT USED. ANOTHER OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT BILIARY STENT W/UNISTEP PLUS FGE BOSTON SCIENTIFIC H965430500 11556318

    Patients

    Seq Age Sex Outcome Treatment
    1