BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 19531005 · Received June 13, 2024

    Report

    Report Number
    2134243-2024-00009
    Event Type
    Death
    Date Received
    June 13, 2024
    Date of Event
    April 7, 2024
    Report Date
    June 12, 2024
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER ADDITIONAL REQUESTS BY ACIST FOR THE USER FACIITY TO RETURN THE CVI INJECTOR SYSTEM SERIAL NUMBER (B)(6) TO THE ACIST EUROPE SERVICE CENTER FOR EVALUATION, THE USER FACILITY ELECTED NOT TO RETURN THE DEVICE TO ACIST. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ACIST REVIEWED THE DEVICE HISTORY RECORDS FOR THE CVI INJECTOR USED DURING THE EVENT, AND PER PREVIOUS SERVICE VISITS UNRELATED TO THIS EVENT, THERE WERE NO ISSUES NOTED THAT WOULD BE RELATED TO THIS EVENT. THE USER FACILITY IS STILL ACTIVELY USING THE SYSTEM WITHOUT ANY FURTHER COMPLAINTS. THIS REPORT IS CLOSED.

    Additional Manufacturer Narrative · 0

    THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(6), HAS NOT YET BEEN RETURNED TO ACIST. THE CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE USER FACILITY AND THE LOT NUMBERS ARE UNKNOWN. THE CINE-ANGIOGRAMS HAVE BEEN REQUESTED FOR EVALUATION, BUT HAVE NOT YET BEEN RETURNED TO ACIST. A CLINICAL ASSESSMENT BY AN ACIST MEDICAL ADVISORY BOARD MEMBER WILL BE PERFORMED ON THE CINE-ANGIOGRAMS UPON RECEIPT. A FOLLOW-UP REPORT WILL BE SUBMITTED TO THE FDA UPON COMPLETION OF THE CLINICAL ASSESSMENT OF THE CINE-ANGIOGRAMS ASSESSMENT AND COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON 14 MAY 2024, ACIST BECAME AWARE OF AN ADVERSE EVENT WITH A FATAL OUTCOME INVOLVING A PATIENT WHO HAD PRESENTED ON (B)(6) 2024 AT THE (B)(6) [ HOSPITAL] AND, AFTER A CORONARY ANGIOGRAPHY, WAS TRANSFERRED TO THE ICU IN CRITICAL CONDITION. THE PATIENT DIED ON (B)(6) 2024. THE PATIENT UNDERWENT CORONARY EXAMINATION USING THE ACIST CVI INJECTOR. ACIST'S ITALIAN AFFILIATE, (B)(6) HAD NOT RECEIVED A REQUEST FOR SERVICE ON THE INJECTOR OR RECEIVED ANY REPORT OF A MALFUNCTION, AND FROM THE INFORMATION GATHERED BY THE SUB-DISTRIBUTOR, THE INJECTOR IS STILL BEING USED REGULARLY. THE INFORMATION COLLECTED IS THE RESULT OF PHONE CONVERSATIONS WITH THE SUB-DISTRIBUTOR AND A NEWSPAPER ARTICLE. IN THE ARTICLE IT STATES THAT THERE IS AN ONGOING INVESTIGATION AGAINST THE HOSPITAL, AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766669 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Hospitalization| D