BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 2261797 · Received September 19, 2011

    Report

    Report Number
    2134243-2011-00010
    Event Type
    Death
    Date Received
    September 19, 2011
    Date of Event
    August 19, 2011
    Report Date
    September 19, 2011
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACIST ANGIOGRAPHIC CONTRAST INJECTION SYSTEM, MODEL CVI, WAS RETURNED TO ACIST ON (B)(6), 2011 FOR TESTING. THE INJECTION SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. THERE IS NO EVIDENCE OF DEVICE MALFUNCTION BASED ON THE DATA FROM THE ANALYSIS OF THE INJECTOR. THE DISPOSABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE USER FACILITY; THEREFORE, NO ANALYSIS COULD BE MADE OF THOSE ITEMS. ACIST'S MEDICAL ADVISORY BOARD MEMBERS REVIEWED THE INFORMATION AND A COPY OF THE CINE-ANGIOGRAM PROVIDED BY THE HOSPITAL OF THE EVENT. THE PT HAD A THROMBOTIC LESION IN THE PROXIMAL LAD THAT WAS STENTED. THE FIRST IMAGES OF THE CINE-ANGIOGRAM ARE OF A LEFT CORONARY INJECTION. THE FLOW IN THE VESSELS IS EITHER DIMINISHED (INCOMPLETE FILLING OF THE LAD) OR THE IMAGE WAS STOPPED BEFORE THE FILLING WAS COMPLETE. THE NEXT IMAGES SHOW CPR BEING PERFORMED. THERE WAS NO AIR SEEN IN THE FIRST FEW IMAGES. A SMALL AMOUNT OF AIR IS VISIBLE ON CINE NUMBER 10 AND CINE NUMBER 14. THERE IS NO EVIDENCE OF DEVICE MALFUNCTION BASED ON THE RESULTS OF THE INJECTOR TESTING. ACIST'S RISK MANAGEMENT HAS APPROPRIATE RISK MITIGATIONS IN PLACE FOR POTENTIAL AIR EMBOLISM DUE TO USER ERROR, INCLUDING LABELING DESCRIBING AIR BUBBLE PRECAUTIONS AND THE USER MANUAL WHICH GUIDES THE USER THROUGH SET-UP AND PURGE OF THE INJECTOR SYSTEM. THIS REPORT IS CLOSED.

    Description of Event or Problem · 1

    NARRATIVE: USER FACILITY REPORTED ON (B)(6), 2011, THAT AIR WAS INJECTED INTO A PT'S ARTERY DURING A CORONARY ANGIOGRAPHY. ON (B)(6), 2011, ACIST BECAME AWARE THAT THE PT DIED. IT WAS REPORTED THAT THE PT EXPERIENCED ST SEGMENT ELEVATION, STENT THROMBOSIS, AND SUDDEN CARDIAC ARREST. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS GIVEN TO THE PT. THE PT'S PRE-EXISTING CONDITION WAS CRITICAL. THE PT HAD AN ACTIVE STENT IN PLACE AND WAS NOT TAKING HIS PRESCRIBED MEDICINES. THE PT HAD A HISTORY OF DRUG USE (HEROIN, COCAINE) AND HAD APPROXIMATELY 2 - 3 PRIOR EMERGENCY HOSPITAL VISITS. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR