BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 2492880 · Received March 9, 2012

    Report

    Report Number
    MW5024604
    Event Type
    Injury
    Date Received
    March 9, 2012
    Report Date
    March 9, 2012
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USING FULLY COVERED WALL STENT AND DURING WITHDRAWAL OF THE DEPLOYMENT DEVICE IT HUNG UP. WITH SOME SCOPE MANIPULATION WE WERE ABLE TO FINISH PULLING THE DEPLOYMENT DEVICE AND KEEP THE STENT IN PLACE. DR (B)(6) REPORTS THAT THIS IS THE SECOND TIME THAT THIS HAS HAPPENED WITH THIS TYPE OF STENT IN THE LAST WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC WALL STENT FGE BOSTON SCIENTIFIC 14830376 7053

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Disability