BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIEMENS

    MDR report key: 222835 · Received April 27, 1999

    Report

    Report Number
    222835
    Event Type
    Death
    Date Received
    April 27, 1999
    Date of Event
    April 13, 1999
    Report Date
    April 26, 1999
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC
    Product Code
    IZO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THIS PT CAME TO THE CATH LAB EMERGENTLY. SHE WAS HEMODYNAMICALLY UNSTABLE WITH A SYSTOLIC PRESSURE OF 60 MMHG. SHE WAS PREPPED AND DRAPED IN STANDARD MANNER. ACCESS WAS GAINED IN THE LEFT FEMORAL ARTERY. CORONARY ANGIOGRAPHY WAS PERFORMED, FINDING A CLOT IN THE LEFT MAIN ARTERY. A SURGEON WAS CONSULTED. A WIRE WAS PLACED IN THE LEFT MAIN ARTERY. THEN AN ANGIO-JET CATHETER WAS PLACED IN THE SAME ARTERY. BEFORE THE CLOT COULD BE REMOVED, THE FLUOROSCOPE EQUIPMENT FAILED. VERY QUICKLY AFTERWARDS HER PRESSURE DROPPED TO 40 MMHG. A PORTABLE C-ARM WAS BROUGHT IN. A BALLOON CATHETER WAS INSERTED JUST BEFORE ARREST. PT DID ARREST AND DIED THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS * IZO SIEMENS MEDICAL SYSTEMS, INC 8806804 G5307 *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| L