BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSTE B-RAIL

    MDR report key: 3225999 · Received July 2, 2013

    Report

    Report Number
    3225999
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    April 30, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BEST VASCULAR, INC
    Product Code
    MOU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS UNABLE TO CORRECTLY DEPLOY BRACHYTHERAPY CATHETER (ABR-0346) AS THERE WAS A 'KINK' IN THE CATHETER. ANOTHER CATHETER HAD TO BE USED. NO IMPACT TO THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CATHETERIZATION WITH ANGIOGRAPHY FOLLOWED BY INTRAVASCULAR BRACHYTHERAPY DUE TO THE PROXIMAL AND DISTAL STENOTIC PORTION OF THE RIGHT FEMORAL POPLITEAL GRAFT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301745 NOVOSTE B-RAIL BRACHY CATHETER MOU BEST VASCULAR, INC * BW0135

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR