BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST CVI ANGIOGRAPHIC INJECTION

    MDR report key: 10351266 · Received July 24, 2020

    Report

    Report Number
    10351266
    Event Type
    Death
    Date Received
    July 24, 2020
    Date of Event
    July 13, 2020
    Report Date
    July 17, 2020
    Manufacturer
    ACIST
    Product Code
    DXT
    UDI-DI
    10841716101196
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    DIAGNOSTIC HEALTH CATH UTILIZING ACIST MEDICAL DEVICE, IMMEDIATELY ON INITIAL INJECTION OF CONTRAST, THE PT EXPERIENCED CARDIOPULMONARY ARREST. UNABLE TO RETURN SPONTANEOUS CIRCULATION AND RESPIRATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782974 ACIST CVI ANGIOGRAPHIC INJECTION ACIST INJECTOR DXT ACIST 017738 10841716101196

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death