BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDIGUARD IAB CATHETER

    MDR report key: 45926 · Received October 24, 1996

    Report

    Report Number
    1222008-1996-00054
    Event Type
    Malfunction
    Date Received
    October 24, 1996
    Date of Event
    September 20, 1996
    Report Date
    September 25, 1996
    Manufacturer
    BARD VASCULAR SYSTEM
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSE NOTICED BLOOD IN CATHETER AND A BALLOON CHECK CATHETER ALARM CONDITION FOLLOWED PERFUSIONIST WAS CALLED IN TO CONFIRM THE RUPTURE. BALLOON WAS REMOVED AND A HOLE WAS VISIBLE AT PROXIMAL END. PT IS STABLE W/O AN IAB SUPPORT, NO APPARENT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDIGUARD IAB CATHETER Implant INTRA-AORTIC BALLOON DSP BARD VASCULAR SYSTEM NA 13GF0207

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR