BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST MEDICAL SYSTEMS INJECTOR

    MDR report key: 15242596 · Received August 16, 2022

    Report

    Report Number
    MW5111532
    Event Type
    Injury
    Date Received
    August 16, 2022
    Date of Event
    July 25, 2022
    Report Date
    August 15, 2022
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING CARDIAC CATHETERIZATION PROCEDURE, WHEN ADVANCING CATHETER INTO AORTA THE RCA(RIGHT CORONARY ARTERY) WAS SEEN TO BE OCCLUDED. THERE WERE MULTIPLE FILLING DEFECTS EITHER CONSISTENT WITH AIR OR CLOT. MAY HAVE BEEN AN EMBOLUS OUT OF THE CORONARY INTO THE AORTA. PATIENT REQUIRED BRIEF INTUBATION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848235 ACIST MEDICAL SYSTEMS INJECTOR INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention