BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 10140859 · Received June 10, 2020

    Report

    Report Number
    2134243-2020-00004
    Event Type
    Death
    Date Received
    June 10, 2020
    Date of Event
    May 11, 2020
    Report Date
    May 19, 2020
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(4), WAS RETURNED TO ACIST ON 25MAY2020. THE INJECTOR SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. THE CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE USER FACILITY AND THE LOT NUMBERS USED WERE NOT PROVIDED; THEREFORE ACIST IS UNABLE TO INVESTIGATE THESE ITEMS. ACIST'S MEDICAL ADVISOR REVIEWED A COPY OF THE CINE-ANGIOGRAMS AND INFORMATION RECEIVED FROM THE USER FACILITY FOR THE EVENT: THE FILMS ARE CONSISTENT WITH THE DESCRIPTION OF EVENTS IN THE CASE FILES. THE INITIAL ANGIOGRAPHY SHOWS A DIAGNOSTIC CATHETER IN THE LEFT MAIN ARTERY. THERE IS NO EVIDENCE OF DISSECTION IN THE LEFT MAIN OR PROXIMAL VESSELS. THE ANGIOGRAM APPEARANCE IS MOST CONSISTENT WITH AN AIR EMBOLUS HAVING OCCURRED IMMEDIATELY PRIOR TO THE EVENT. THE INITIAL INJECTION DEMONSTRATES SLOW FLOW/OCCLUSION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND LEFT CIRCUMFLEX ARTERY (LCX). THE SUBSEQUENT IMAGES SHOW ATTEMPTS TO RE-ESTABLISH FLOW IN THE CORONARIES WHILE CPR IS BEING PERFORMED. THERE IS EVIDENCE OF TRANSIENT IMPROVEMENT OF FLOW INTO CIRCUMFLEX, ALTHOUGH IT NEVER APPEARS NORMAL AND THE FLOW IN LAD IS NOT RE-ESTABLISHED. THE INSTRUCTIONS FOR USE HAVE BEEN REVIEWED AND NO INADEQUACIES WERE IDENTIFIED REGARDING WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE USE OF THE DEVICE. THERE IS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THIS EVENT AND NO INADEQUACIES RELATED TO THE DEVICE LABELING/INSTRUCTIONS FOR USE. THE CAUSE OF THE EVENT IS INCONCLUSIVE. THIS EVENT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED, WHILE PERFORMING A CORONARY ANGIOGRAPHY UPON THE FIRST INJECTION OF CONTRAST INTO THE PATIENT, THE PHYSICIAN OBSERVED THAT CONTRAST WAS STAGNATING IN THE LEFT CIRCUMFLEX ARTERY (LCX) AND THAT THERE WAS NO CONTRAST IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PATIENT EXPERIENCED CHEST PAIN, ABNORMAL HEART RHYTHM AND HYPOTENSION. THE PATIENT IMMEDIATELY WAS ADMINISTERED CARDIOPULMONARY RESUSCITATION (CPR) DUE TO ASYSTOLE WITH THE DIFFERENTIAL BEING DISSECTION, AIR OR THROMBUS. ATTEMPTS WERE MADE TO REVIVE THE PATIENT, BUT ALL ATTEMPTS WERE UNSUCCESSFUL, AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601153 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death