BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B-RAIL

    MDR report key: 4507759 · Received February 2, 2015

    Report

    Report Number
    4507759
    Event Type
    Malfunction
    Date Received
    February 2, 2015
    Date of Event
    January 29, 2015
    Report Date
    February 2, 2015
    Manufacturer
    BEST VASCULAR, INC.
    Product Code
    MOU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NOVOSTE B-RAIL INSERTED BY THE INTERVENTIONAL CARDIOLOGIST INTO CIRCUMFLEX ARTERY FOR INTRA-CORONARY RADIATION THERAPY TREATMENT. RADIATION SEEDS WOULD NOT DELIVER THROUGH CATHETER, CATHETER WAS REMOVED AND A SECOND DEVICE USED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74351 B-RAIL INTRAVASCULAR RADIATION DELIVERY SYSTEM MOU BEST VASCULAR, INC. * BW0138

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR