BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 8078286 · Received November 16, 2018

    Report

    Report Number
    2134243-2018-00023
    Event Type
    Death
    Date Received
    November 16, 2018
    Date of Event
    October 11, 2018
    Report Date
    October 11, 2018
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACIST MULTI-USE SYRINGE KIT, MODEL A2000, LOT 05318W. ACIST SINGLE-USE MANIFOLD KIT, MODEL BT2000, LOT 05318J. ACIST ANGIOTOUCH HAND CONTROLLER KIT, MODEL AT-P65, LOT 14418P. THE ACIST ANGIOGPRAPHIC INJECTION SYSTEM, MODEL CVI, USED DURING THE EVENT, WAS RECEIVED AT ACIST ON OCTOBER 19, 2018, AND INVESTIGATION IS IN PROCESS. THE CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED. LOT NUMBERS OF THE CONSUMABLE KITS WERE PROVIDED AND A DEVICE HISTORY REVIEW WILL BE COMPLETED AS PART OF THE INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, ACIST WILL SUBMIT A FOLLOW-UP REPORT TO FDA.

    Additional Manufacturer Narrative · 1

    THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(4) WAS RETURNED TO ACIST ON OCTOBER 19, 2018, AND FUNCTIONALLY TESTED AND MET PRE-ESTABLISHED SPECIFICATIONS. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THIS EVENT BASED ON THE DATA FROM THE ANALYSIS OF THE INJECTION SYSTEM. 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. REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED ON NOVEMBER 27, 2018, FOR THE FOLLOWING CVI CONSUMABLE KIT LOTS USED DURING THE EVENT: ACIST MULTI-USE SYRINGE KIT, MODEL A2000, LOT 05318W, ACIST SINGLE-USE MANIFOLD KIT, MODEL BT2000, LOT 05318J, AND ACIST ANGIOTOUCH HAND CONTROLLER KIT, MODEL AT-P54, LOT 14418P. THIS REVIEW CONFIRMED THAT THERE WERE NO MANUFACTURING QUALITY ISSUES FOR THESE LOTS RELATED TO THE REPORTED EVENT. A COPY OF THE CINE-ANGIOGRAM WAS REQUESTED BUT WAS NOT AVAILABLE FROM THE USER FACILITY. BASED ON TESTING AND EVALUATION OF THIS CVI INJECTION SYSTEM, THERE IS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THE REPORTED EVENT. THE CAUSE OF THE EVENT IS INCONCLUSIVE. THIS REPORT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED: DURING A NON-EMERGENT INTERVENTIONAL CORONARY ANGIOGRAPHY, AFTER INSERTING THE GUIDE CATHETER INTO THE PATIENT, A COLUMN OF AIR WAS INJECTED INTO THE PATIENT'S LEFT CORONARY ARTERY (LCA) UPON THE FIRST INJECTION OF CONTRAST. NO FLOW WAS VISIBLE IN THE PATIENT'S LCA. THE PATIENT'S EXPERIENCED ST-SEGMENT ELEVATION AND HYPOTENSION. PATIENT DEATH OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919515 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI SEE SECTION H-3

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death ABBOTT VASCULAR COPILOT CONTROL VALVE CAT #100331| BOSTON SCIENTIFIC GUIDE CATHETER CAT #H7493896907| OMNIPAQUE 350| TERUMO INTRODUCER SHEATH CAT #35-1060