BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 16728130 · Received April 12, 2023

    Report

    Report Number
    2134243-2023-00005
    Event Type
    Death
    Date Received
    April 12, 2023
    Date of Event
    February 3, 2023
    Report Date
    April 11, 2023
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER WAS NOT PROVIDED BY THE USER FACILITY AND THE SYSTEM WILL NOT BEEN RETURNED FOR EVALUATION. THE USER FACILITY REQUESTED STAFF TRAINING IN LIEU OF EVALUATION OF THE SYSTEM IN QUESTION, AND THE TRAINING WAS PROVIDED BY AN ACIST CLINICAL SPECIALIST SHORTLY AFTER THE EVENT. REVIEW OF THE COMPLAINT HISTORY RECORD FOR METHODIST MANSFIELD MED CTR IN MANSFIELD, TEXAS, SHOWED NO PREVIOUS RELATED COMPLAINTS. THE CONSUMABLES USED DURING THE EVENT WERE DISCARDED AND THE LOT NUMBERS ARE NOT KNOWN. THE CINE-ANGIOGRAMS TAKEN DURING THE EVENT HAVE BEEN REQUESTED FOR EVALUATION, BUT HAVE NOT BEEN RETURNED TO ACIST. A CLINICAL ASSESSMENT BY AN ACIST MEDICAL ADVISORY BOARD MEMBER WILL BE PERFORMED SHOULD THE CINE-ANGIOGRAMS BE RETURNED FOR EVALUATION, AND A FOLLOW-UP REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 0

    ON (B)(6) 2023, DURING A CORONARY ANGIOGRAPHY USING THE ACIST INJECTION SYSTEM, MODEL CVI, ON A 30-YEAR-OLD FEMALE PATIENT BEING TREATED FOR NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) WITH ELEVATED TROPONINS, AND CHEST PAIN FOR THREE DAYS PRIOR, THE PATIENT HAD A CORONARY DISSECTION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE DISSECTION WAS SEEN AFTER TWO INJECTIONS OF CONTRAST MEDIA WERE PERFORMED. THE ARTERY COULD NOT BE RE-CANNULATED TO CONTROL THE DISSECTION AND THE PATIENT PASSED AWAY. THE PHYSICIAN PERFORMING THE PROCEDURE HAD REDUCED THE INJECTION SETTINGS ON THE CVI INJECTION SYSTEM DUE TO THE PATIENT'S SIZE AND FRAILTY. THE USER FACILITY INTERIM MANAGER CONTACTED THE ACIST CLINICAL SPECIALIST ON (B)(6) 2023, TO REPORT THIS EVENT. ON (B)(6) 2023, THE ACIST CLINICAL SPECIALIST SPOKE TO THE MANAGER AND CONFIRMED THAT THE USER FACILITY ELECTED TO NOT SEND THE CVI INJECTOR SYSTEM TO ACIST FOR INVESTIGATION THE USER FACILITY REQUESTED A REFRESHER IN-SERVICE TRAINING. THE ACIST CLINICAL SPECIALIST PROVIDED THIS TRAINING. NOTE: THIS EVENT WAS NOT REPORTED TO ACIST CUSTOMER SUPPORT UNTIL MARCH 15, 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1456189 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Death