BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSTE BETA-CATH IVB

    MDR report key: 3208703 · Received June 12, 2013

    Report

    Report Number
    3208703
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 12, 2013
    Manufacturer
    BEST VASCULAR, INC
    Product Code
    MOU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    WHEN THE SYSTEM WAS ENGAGED TO RETURN THE RADIATION SOURCES, THE SOURCES DID NOT IMMEDIATELY RETURN AS EXPECTED. THE SOURCES WERE STUCK IN THE AREA OF THE AORTA. THERE WAS AN APPROXIMATELY A 1 MINUTE DELAY WHILE THE ENTIRE SYSTEM WAS REMOVED TO PREVENT CONTINUED EXPOSURE.THIS HAS HAPPENED BEFORE WITH THE DEVICE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?VASCULAR BRACHYTHERAPY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267282 NOVOSTE BETA-CATH IVB DEVICE, INTRAVASCULAR BRACHYTHERAPY MOU BEST VASCULAR, INC NOVOSTE 40 MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 *