BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSTE BETACATH SYSTEM

    MDR report key: 1381021 · Received May 5, 2009

    Report

    Report Number
    1381021
    Event Type
    Malfunction
    Date Received
    May 5, 2009
    Date of Event
    April 28, 2009
    Report Date
    May 5, 2009
    Manufacturer
    BEST VASCULAR, INC.
    Product Code
    IWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NOVOSTE BETACATH SYSTEM: THE ICRT CATHETER WAS KINKED SO THE SR-90 RADIOACTIVE TRAIN COULD NOT BE SENT BACK TO THE DEVICE. AFTER THE TREATMENT WAS FINISHED, MD TIED TO PUSH THE SR-90 RADIOACTIVE SOURCE BACK TO THE DEVICE, THE SOURCELEFT THE TREATMENT AREA AND WAS STUCK IN THE CATHETER JUNCTION OUTSIDE OF THE PATIENT'S BODY. MD SAID THE CATHETER HAD A KINK AT THE JUNCTION. THE CATHETER WAS PULLED OUT FROM THE PATIENT'S BODY AND DUMPED IN A SHIELDED TRANSPORTATION BOX WITH WHOLE DEVICE. THE PATIENT AND ROOM WAS SURVEYED USING RADIATION SURVEY METER. NO RADIATION WAS FOUND INSIDE THE PATIENT BODY AND IN THE TREATMENT ROOM OF THE CARDIAC CATH LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOSTE BETACATH SYSTEM CATHETER, BRACHYTHERAPY, INTRACAVITY, ICRT IWJ BEST VASCULAR, INC. * BETA-CATH 3.5R SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 *