BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 10517921 · Received September 10, 2020

    Report

    Report Number
    2134243-2020-00010
    Event Type
    Death
    Date Received
    September 10, 2020
    Date of Event
    August 12, 2020
    Report Date
    August 12, 2020
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    UDI-DI
    40841716101876
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H2: THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(6), WAS RETURNED TO ACIST ON AUGUST 19, 2020. THE INJECTOR SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. THE CONSUMABLES USED DURING THE EVENT WERE DISCARDED AND THE LOT NUMBERS ARE NOT KNOWN. ACIST HAS NOT YET RECEIVED A COPY OF THE CINE-ANGIOGRAMS OF THE EVENT. IF THE CINE-ANGIOGRAMS ARE RECEIVED, THEY WILL BE REVIEWED BY ACIST'S MEDICAL ADVISOR. UPON COMPLETION OF THESE REVIEWS, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA. 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. THERE IS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THIS EVENT AND NO INADEQUACIES RELATED TO THE DEVICE LABELING/INSTRUCTIONS FOR USE.

    Additional Manufacturer Narrative · 0

    H2: DESPITE SEVERAL REQUESTS BY ACIST FOR ADDITIONAL INFORMATION AND A COPY OF THE CINE-ANGIOGRAMS, THE USER FACILITY ELECTED NOT TO PROVIDE THE ADDITIONAL INFORMATION OR A COPY OF THE CINE-ANGIOGRAMS. SHOULD THIS INFORMATION BECOME AVAILABLE AT A FUTURE DATE, ACIST WILL SUBMIT A FOLLOW-UP REPORT TO FDA. THIS REPORT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    PATIENT AGE AND BIRTHDATE ARE UNKNOWN. ESTIMATED AGE AND BIRTHDATE ARE ENTERED INTO THESE FIELDS. PATIENT WEIGHT IS NOT KNOWN. THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(4), WAS REQUESTED TO BE RETURNED FOR EVALUATION ON (B)(6) 2020. THE CONSUMABLE KITS USED DURING THE PROCEDURE WERE DISCARDED AND THE LOT NUMBERS ARE NOT KNOWN. PATIENT INFORMATION HAS NOT YET BEEN RECEIVED, AND COPIES OF THE CINE-ANGIOGRAMS HAVE BEEN REQUESTED TO BE RETURNED TO ACIST FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA.

    Description of Event or Problem · 1

    DURING A CATHETERIZATION PROCEDURE, AIR WAS INJECTED INTO A PATIENT. THE USER REPORTED THAT THE TRANSDUCER WAS NOT PROVIDING A PRESSURE WAVEFORM; THE USER REPLACED THE TRANSDUCER. THE USER REPEATED THE SETUP OF THE CONSUMABLE KITS WITH THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI. AT THE START OF THE PROCEDURE, UPON THE FIRST INJECTION OF CONTRAST, THE USER OBSERVED A SMALL AMOUNT OF AIR. POST THE AIR INJECTION, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981001 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI 40841716101876

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death