BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 909011 · Received September 5, 2007

    Report

    Report Number
    2134243-2007-00008
    Event Type
    Injury
    Date Received
    September 5, 2007
    Date of Event
    August 9, 2007
    Report Date
    September 6, 2007
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION: THE ANGIOGRAPHIC INJECTOR WAS TAKEN OUT OF SERVICE IN 2007 AND RETURNED TO ACIST MEDICAL SYSTEMS ON FIVE DAYS LATER. THE ANGIOGRAPHIC INJECTOR WAS TESTED AND MET ALL PRE-ESTABLISHED SPECIFICATIONS. DISPOSABLE KITS USED DURING THE EVENT WERE NOT RETAINED BY THE USER FACILITY; THEREFORE, NO ANALYSIS COULD BE PERFORMED ON THOSE ITEMS. CINEANGIOGRAM IS BEING RETURNED BY THE USER FACILITY TO ACIST; UPON COMPLETION OF REVIEW BY ACIST'S MEDICAL ADVISORY BOARD, A SUPPLEMENT REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED: DURING A CAROTID STENT PROCEDURE, USING THE ACIST ANGIOGRAPHIC CONTRAST INJECTION SYSTEM, AIR WAS INJECTED INTO A PATIENT, AND THE PATIENT SUFFERED A STROKE. THE PATIENT WAS APHASIC AFTER THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L