BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACIST

    MDR report key: 485127 · Received September 18, 2003

    Report

    Report Number
    2134243-2003-00006
    Event Type
    Other
    Date Received
    September 18, 2003
    Date of Event
    March 5, 2002
    Report Date
    September 18, 2003
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE ACIST DEVICE, AIR WAS INJECTED INTO A PATIENT'S RIGHT CORONARY ARTERY (RCA). THERE WERE NO REPORTS OF AN ADVERSE REACTION OTHER THAN TRANSIENT CHEST PAIN AND ST ELEVATION. THE CUSTOMER REPORTED THE PATIENT TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. CMS2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other