BEUDAMED
    FDA Adverse Event Summary report: N

    SHEATHLESS INTRA-AORTIC COUNTER PULSATION BALLOON, 40 CC

    MDR report key: 16459 · Received February 25, 1994

    Report

    Report Number
    MW4000481
    Date Received
    February 25, 1994
    Date of Event
    February 13, 1994
    Report Date
    February 25, 1994
    Manufacturer
    KONTRON INSTRUMENTS, INC.
    Product Code
    DSP
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A PT HOSPITALIZED IN THE CCU BECAME SHORT OF BREATH AND REQUIRED MECHANICAL VENTILATORY SUPPORT FOR TREATMENT OF PULMONARY EDEMA RELATED TO ISCHEMIC MITRAL REGURGITATION. AT APPROX 0400 IN SUNDAY 2/13/94 THE PT WAS TAKEN TO THE CARDIAC CATHETERIZATION LABORATORY AND AN INTRA-AORTIC BALLOON WAS PLACED VIA THE FEMORAL ARTERY BY A CARDIOLOGY STAFF PHYSICIAN WITHOUT DIFFICULTY. THIS BALLOON WAS CONNECTED TO A BALLOON PUMP, AND THE SYSTEM FUNCTIONED WELL, WITH CLINICAL IMPROVEMENT OF THE PT AND WITH APPROPRIATE ARTERIAL WAVEFORMS WHICH CONFIRMED APPROPRIATE FUNCTION. AT APPROXIMATELY 14:50 ON 2/13/94, ABOUT 10 HOURS AFTER PLACEMENT, THE BALLOON WAS NOTED TO HAVE FAILED, WITH BLOOD BEING SEEN IN THE GAS LINE. THE PT SUFFERED CARDIOVASCULAR COLLAPSE WITHIN A FEW MINUTES AND WAS UNABLE TO BE RESUSCITATED. HE WAS PRONOUNCED DEAD AT APPROXIMATELY 15:35. RPTR BELIEVES THAT HIS DEATH WAS PRECIPITATED BY THE BALLOON FAILURE BECAUSE OF DEPENDENCE OF THE PT'S VITAL SIGNS ON PROPER FUNCTION OF THE BALLOON. NO RECOMMENDATION TO WITHDRAW THESE BALLOONS HAS BEEN MADE BY THE CARDIOLOGY SERVICE, SINCE THIS IS AN ISOLATED EVENT AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHEATHLESS INTRA-AORTIC COUNTER PULSATION BALLOON, 40 CC DSP KONTRON INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *