BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC INTRODUCER MODEL # 5661ST

    MDR report key: 1220921 · Received November 4, 2008

    Report

    Report Number
    MW5008882
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC/GUIDANT
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE RADIOPAQUE RING FROM THE CONVOY SHEATH WAS RETAINED IN THE PT'S VEIN. ATTEMPTS TO RETRIEVE THE RING WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC INTRODUCER MODEL # 5661ST CONVOY SHEATH DYB BOSTON SCIENTIFIC/GUIDANT 5661ST

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR