BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRA-AORTIC BALLOON, 9 FR DOUBLE LUMEN

    MDR report key: 12647 · Received March 3, 1994

    Report

    Report Number
    12647
    Event Type
    Death
    Date Received
    March 3, 1994
    Date of Event
    February 28, 1994
    Report Date
    March 3, 1994
    Manufacturer
    KONTRON INSTRUMENTS, INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC CATH, WITH SOFT TIP CATHETER, THE LEFT MAIN CORONARY DISSECTED CAUSING AN MI AND CARDIAC ARREST. DURING RESUSCITATION, ATTEMPT WAS MADE TO INSERT IABP IN LEFT FEMORAL ARTERY. THIS WAS UNSUCCESSFUL DUE TO VERY TORTUOUS VESSELS; BLOOD PRESSURE COULD NOT BE MAINTAINED AND PT TAKEN TO OR. PERFORATION OF ABDOMINAL AORTIC ANEURYSM WAS DISCOVERED AND PT COULD NOT BE RESUSCITATED. THE MD DOING THE HEART CATH DOES NOT FEEL THAT THE DISSECTION WAS DEVICE RELATED THOUGH HE STATES THAT THE PT HAD TORTUOUS AND CALCIFIED BLOOD VESSELS. HE USED SOFT TIP ANGIO CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALLOON, 9 FR DOUBLE LUMEN INTRA-AORTIC BALLOON DSP KONTRON INSTRUMENTS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death AL-S TRIGUIDE| PTCA CATHETER BY SCIMED