BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 8075781 · Received November 15, 2018

    Report

    Report Number
    2134243-2018-00024
    Event Type
    Death
    Date Received
    November 15, 2018
    Date of Event
    September 12, 2018
    Report Date
    October 19, 2018
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACIST RECEIVED THE EVENT INFORMATION FROM THE FDA VIA A NOTIFICATION LETTER PROVIDING INFORMATION OF A VOLUNTARY USER FACILITY MEDWATCH (MW5080286). REVIEW OF ACIST'S COMPLAINT DATABASE DID NOT IDENTIFY AN EXISTING COMPLAINT FOR THIS EVENT, THUS MINIMAL INFORMATION ON THE EVENT IS AVAILABLE. THE NAME OF THE USER FACILITY, DEVICE SERIAL NUMBER, AND LOT NUMBERS OF THE CONSUMABLE KITS WERE NOT PROVIDED; THEREFORE, ACIST IS UNABLE TO INVESTIGATE THIS EVENT. THIS REPORT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED: PATIENT WAS SET UP FOR A DIAGNOSTIC CORONARY ANGIOGRAPHY FOR MEDICAL CLEARANCE TO UNDERGO A CHOLECYSTECTOMY. INITIAL "PUFF" INJECTION OF CONTRAST DEMONSTRATED THE CATHETER TO BE IN THE VESSEL. THE USER NOTED AIR IN THE CORONARY SYSTEM. ATTEMPTS TO REMOVE THE AIR WERE UNSUCCESSFUL. PATIENT WENT INTO PEA (PULSELESS ELECTRICAL ACTIVITY) CARDIAC ARREST. RESUSCITATIVE MEASURES WERE UNSUCCESSFUL AND THE PATIENT EXPIRED. NOTE: THE EVENT INFORMATION WAS RECEIVED BY ACIST VIA A LETTER DATED OCTOBER 9, 2018, FROM FDA (NOTIFICATION OF USER FACILITY MEDWATCH REPORT MW5080286). CONFIRMATION MADE ON OCTOBER 19, 2018, THAT THIS WAS A NEW EVENT (NOT PREVIOUSLY REPORTED TO ACIST). REQUEST WAS MADE TO FDA TO OBTAIN THE DEVICE SERIAL NUMBER AND/OR INITIAL REPORTER INFORMATION; FDA RESPONDED THAT THEY WERE UNABLE TO PROVIDE THIS INFORMATION. INJECTOR SERIAL NUMBER AND FACILITY NAME ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914393 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death