BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACIST

    MDR report key: 485740 · Received September 20, 2003

    Report

    Report Number
    2134243-2003-00009
    Event Type
    Other
    Date Received
    September 20, 2003
    Date of Event
    August 19, 2003
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    DURING A DIAGNOSTIC ANGIOGRAM, AIR WAS INJECTED INTO THE PATIENT'S RIGHT CORONARY ARTERY (RCA). CUSTOMER REPORTS THEY HAD ALREADY PERFORMED AN RCA INJECTION PRIOR TO THE ONE THAT INTRODUCED AIR. THE PATIENT EXPERIENCED BRADYCARDIA AND WAS TREATED WITH ATROPINE. PATIENT STABILIZED AND DID NOT REPORT CHEST PAIN OR ANY OTHER COMPLICATIONS. THE HOSPITAL STAFF REPORTS NOT KNOWING THE ORIGIN OF THE AIR NOR DID THEY RECALL LOOKING FOR OR OBSERVING AIR IN THE LINE WHEN THEY WERE INJECTING.

    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 Required Intervention