BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST CVI

    MDR report key: 14653104 · Received June 10, 2022

    Report

    Report Number
    14653104
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    March 29, 2022
    Report Date
    May 17, 2022
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PHYSICIAN PERFORMING THE CASE NOTICED AN AIR BUBBLE INJECTED INTO THE PATIENT'S CORONARY ARTERY. HE ATTRIBUTES THIS AIR BUBBLE TO THE INJECTOR SYSTEM AND IS CONCERNED ABOUT IT'S RELIABILITY IN ACCORDANCE WITH PATIENT SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630451 ACIST CVI INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. 016795 036221

    Patients

    Seq Age Sex Outcome Treatment
    1 29565 DA Unknown