BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C.R. BARD, INC.

    MDR report key: 125337 · Received October 8, 1997

    Report

    Report Number
    MW1012271
    Event Type
    Injury
    Date Received
    October 8, 1997
    Date of Event
    October 6, 1997
    Report Date
    October 8, 1997
    Manufacturer
    C.R. BARD, INC.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    INTRA-AORTIC BALLOON WAS INSERTED UNDER FLUOROSCOPY. THE PUMPED ALARMED "KINKED" AND AUGMENTATION WAS LOST. THE PT'S LEG WAS REPOSITIONED AND AUGMENTATION RESUMED AND WAS EXCELLENT (THE PT WAS VERY BALLOON DEPENDENT). THE PT WAS A DNR STATUS AND EXPIRED SOMETIME LATER THAT SHIFT. NO SIGNS OF BALLOON PERFORATION WERE PRESENT (NO BLOOD NOTED IN EXTRACORPORAL TUBING AND AUGMENTATION WAS GOOD OTHER THAN TIME NOTED ABOVE). AFTER THE PT EXPIRED, DRY POWDERED BLOOD CLOTS WERE NOTED INSIDE THE BALLOON CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C.R. BARD, INC. INTRA AORTIC BALLOON DSP C.R. BARD, INC. 9.0 40 CC SHEATHLESS *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention