BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 860729 · Received June 4, 2007

    Report

    Report Number
    2134243-2007-00004
    Event Type
    Injury
    Date Received
    June 4, 2007
    Date of Event
    May 10, 2007
    Report Date
    June 1, 2007
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANGIOGRAPHIC INJECTOR WAS TAKEN OUT OF SERVICE IN 2007 AND RETURNED TO ACIST MEDICAL SYSTEMS ON MAY 17, 2007. FUNCTIONAL TESTING OF THE ANGIOGRAPHIC INJECTOR IS CURRENTLY BEING PERFORMED. DISPOSABLE KITS USED DURING THE PROCEDURE WERE RETURNED TO ACIST MEDICAL SYSTEMS AND TESTED UNDER SIMULATED USE AND PASSED FUNCTIONAL TESTING. THE USER FACILITY REPORTED THAT AN ADD'L COMPONENT WAS USED IN CONJUNCTION WITH THE ACIST DISPOSABLE KIT. AS STATED IN THE ACIST USER MANUAL, USING ANY ADD'L COMPONENTS (E.G., MANIFOLDS, CONNECTOR TUBING) IS A CONTRAINDICATION. THE CINEANGIOGRAM FROM THE PROCEDURE WAS REVIEWED BY ACIST'S MEDICAL ADVISORY. THE FIRST RUN OF THE CINEANGIOGRAM SHOWED EVIDENCE OF A SIGNIFICANT AIR EMBOLISM OBSTRUCTING BLOOD FLOW IN THE MID LAD ARTERY, WHICH WAS PRESENT FROM THE FIRST FRAME OF THE ANGIOGRAM. IN ADDITION, THERE WAS A SMALL AIR EMBOLISM SEEN GOING DOWN THE CIRCUMFLEX (WITHOUT OBSTRUCTION) DURING THE INJECTION. ON THE SECOND RUN OF THE LEFT CORONARY, ALL OF THE AIR HAD CLEARED AND THERE WAS NORMAL BLOOD FLOW. THE LEFT VENTRICULAR ANGIOGRAM AT THE END OF THE CASE SHOWED A LOW NORMAL TO SLIGHTLY REDUCED GLOBAL LV FUNCTION. UPON COMPLETION OF FUNCTIONAL TESTING OF THE ANGIOGRAPHIC INJECTOR, A SUPPLEMENT REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED: WHILE PERFORMING A CARDIAC CATHETERIZATION USING THE ACIST ANGIOGRAPHIC CONTRAST INJECTOR, AIR WAS INJECTED INTO A PT. THE PT EXPERIENCED CARDIAC ARREST AND WAS EXTUBATED AND RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. E2000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening