BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRA-AORTIC BALLOON

    MDR report key: 13183 · Received May 11, 1994

    Report

    Report Number
    MW1001938
    Event Type
    Injury
    Date Received
    May 11, 1994
    Date of Event
    April 30, 1994
    Report Date
    May 2, 1994
    Manufacturer
    KONTRON INSTRUMENTS, INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED A SMALL PIN-HOLE LEAK IN AN INTRA-AORTIC BALLOON. DRIED BLOOD SPECS WERE NOTED IN THE EXTRA-CORPOREAL TUBING. REMOVAL WAS DIFFICULT AND SOMEWHAT FORCED. GROSS EXAM OF THE BALLOON REVEALED DRIED BLOOD IN THE TIP OF THE BALLOON, AND A LARGE STRETCH TEAR APPROX 1.5 CM IN LENGTH. ANOTHER INTRA-AORTIC BALLOON WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALLOON INTRA-AORTIC BALLOON DSP KONTRON INSTRUMENTS, INC. 9.0 FR. 40 CC DL

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention