BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 21203140 · Received January 21, 2025

    Report

    Report Number
    2134243-2025-00001
    Event Type
    Death
    Date Received
    January 21, 2025
    Date of Event
    November 27, 2024
    Report Date
    January 21, 2025
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    UDI-DI
    40841716101425
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(6), WAS RECEIVED FOR EVALUATION ON FEBRUARY 4, 2025. THE INJECTION SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE HAVE BEEN REVIEWED AND NO INADEQUACIES WERE IDENTIFIED REGARDING WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR USE OF THE DEVICE. PER THE ACIST CVI USER'S MANUAL, THE AIR COLUMN DETECT SENSOR IS DESIGNED TO AID THE USER IN THE DETECTION OF AIR COLUMNS IN THE INJECTION LINE, BUT IT IS NOT DESIGNED TO REPLACE THE VIGILANCE AND CARE REQUIRED OF THE OPERATOR IN VISUALLY INSPECTING FOR AIR AND CLEARING AIR FROM THE ENTIRE PATIENT KIT AND ANGIOGRAPHIC CATHETER. THE AIR COLUMN DETECT MECHANISM IS TO BE USED IN CONJUNCTION WITH AND TO COMPLEMENT THE USER'S OTHER PROCEDURES FOR PREVENTING AIR INJECTIONS. THIS REPORT IS CLOSED.

    Additional Manufacturer Narrative · 0

    THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(6), HAS NOT YET BEEN RETURNED TO ACIST. THE CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE USER FACILITY AND THE LOT NUMBERS ARE UNKNOWN. THE CINE-ANGIOGRAMS HAVE BEEN REQUESTED FOR EVALUATION BUT HAVE NOT YET BEEN RETURNED TO ACIST. A CLINICAL ASSESSMENT BY AN ACIST MEDICAL ADVISORY BOARD MEMBER WILL BE PERFORMED ON THE CINE-ANGIOGRAMS UPON RECEIPT. A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    DURING A PERCUTANEOUS CORONARY INTERVENTION USING THE ACIST CVI INJECTION SYSTEM, AIR WAS INJECTED INTO A PATIENT. THE AIR INJECTION OCCURRED AFTER INSERTION OF A CORONARY GUIDING CATHETER AND ENGAGEMENT INTO THE LEFT MAIN CORONARY ARTERY AND UPON INJECTION OF CONTRAST MEDIA. THE PATIENT EXPERIENCED CARDIOGENIC CRASH AND SHOCK AND EXPIRED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590609 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI 40841716101425

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization| D