BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT BILLIARY STENT W/UNISTEP PLUS

    MDR report key: 1060068 · Received June 11, 2008

    Report

    Report Number
    3005099803-2008-00673
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Report Date
    May 16, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K982005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED GASTRO-INTESTINAL (GI) STENTING PROCEDURE, THE WALLSTENT 10MM X 60MM "STENT COULD NOT DEPLOY OR OPEN". THE INTENDED IMPLANT SITE FOR THE STENT IS UNK. IT IS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED. THE PT'S STATUS IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT BILLIARY STENT W/UNISTEP PLUS FGE BOSTON SCIENTIFIC H965430500 11043694

    Patients

    Seq Age Sex Outcome Treatment
    1