BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 8533192 · Received April 19, 2019

    Report

    Report Number
    2134243-2019-00008
    Event Type
    Death
    Date Received
    April 19, 2019
    Date of Event
    March 15, 2019
    Report Date
    May 9, 2019
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: ACIST REQUESTED THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CMS2000, SERIAL NUMBER (B)(4), AND CONSUMABLE KITS USED DURING THE EVENT BE RETURNED TO ACIST FOR INVESTIGATION AND EVALUATION. THE USER FACILITY ELECTED NOT TO RETURN THE CMS2000 INJECTION SYSTEM AND CONSUMABLE KITS TO ACIST AND THE LOT NUMBERS OF THE CONSUMABLE KITS WERE NOT PROVIDED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE CMS2000 INJECTION SYSTEM AND THE DEVICE WAS MANUFACTURED ACCORDING TO ACIST SPECIFICATIONS. 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. THE CAUSE OF THE EVENT IS UNKNOWN. THIS REPORT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    ACIST HAS REQUESTED THAT THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CMS2000, SERIAL NUMBER (B)(4), USED DURING THE EVENT, BE SENT TO ACIST OR INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, ACIST WILL SUBMIT A FOLLOW-UP REPORT TO FDA.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), AIR WAS INJECTED INTO THE PATIENT'S LEFT CORONARY ARTERY (LCA). THE PATIENT EXPERIENCED ST-SEGMENT ELEVATION. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL'S ICU; THE PATIENT SUBSEQUENTLY PASSED AWAY ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323513 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CMS2000

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death DEMAX MEDICAL Y-CONNECTOR| VISIPAQUE CONTRAST MEDIA