BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST CVI ANGIOGRAPHIC INJECTION SYSTEM

    MDR report key: 7929681 · Received October 2, 2018

    Report

    Report Number
    MW5080286
    Event Type
    Death
    Date Received
    October 2, 2018
    Date of Event
    September 12, 2018
    Report Date
    September 21, 2018
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS SET UP FOR A DIAGNOSTIC CORONARY ANGIOGRAPHY FOR MEDICAL CLEARANCE TO UNDERGO A CHOLECYSTECTOMY. INITIAL "PUFF" OF DYE DEMONSTRATED THE CATHETER TO BE IN THE VESSEL. THE PROVIDER NOTED AIR IN THE CORONARY SYSTEM. ATTEMPTS TO REMOVE THE AIR WERE UNSUCCESSFUL, PT WENT INTO A PEA ARREST, RESUSCITATIVE MEASURES WERE UNSUCCESSFUL AND THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768487 ACIST CVI ANGIOGRAPHIC INJECTION SYSTEM INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death