BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST CVI

    MDR report key: 14712338 · Received June 15, 2022

    Report

    Report Number
    MW5110354
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    May 20, 2022
    Report Date
    June 13, 2022
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS AN EMERGENT STEMI, WENT INTO V-FIB AND DEFIBRILLATED. PATIENT MADE A LARGE MOVEMENT WITH DEFIBRILLATION AND WITH THE NEXT INJECTION OF CONTRAST. NOTED AIR EMBOLUS. NO CHANGE IN PATIENT CONDITION. REPORTING DUE TO DEVELOPMENT OF AIR EMBOLISM. WILL SUBMIT 2ND REPORT WITH SIMILAR AIR EMBOLUS ISSUE WITH SAME INJECTOR FOR DIFFERENT PATIENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2441618 ACIST CVI INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Other