BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 7976039 · Received October 17, 2018

    Report

    Report Number
    2134243-2018-00021
    Event Type
    Death
    Date Received
    October 17, 2018
    Date of Event
    September 14, 2018
    Report Date
    September 17, 2018
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(4), WAS RECEIVED AT ACIST ON SEPTEMBER 9, 2019. THE INJECTOR SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THE REPORTED EVENT. THE ACIST CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE USER FACILITY AND THE LOT NUMBERS ARE UNKNOWN; THEREFORE, ACIST IS UNABLE TO INVESTIGATE THESE ITEMS. 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. BASED ON THE TESTING AND EVALUATION OF THE CVI INJECTION SYSTEM, THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THIS EVENT. THIS REPORT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    ACIST MEDICAL SYSTEMS, INC., MADE ADDITIONAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION AND THE ACIST ANGIOGRAPHIC SYSTEM USED DURING THE EVENT. TO DATE, THE INJECTION SYSTEM HAS NOT BEEN RETURNED TO ACIST AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. THIS REPORT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    ACIST MEDICAL SYSTEMS, INC. REQUESTED FROM THE USER FACILITY ADDITIONAL INFORMATION ON THE EVENT AND THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI TO BE SENT TO ACIST FOR EVALUATION. THESE ITEMS HAVE NOT BEEN RECEIVED BY ACIST TO DATE. UPON RECEIPT OF ADDITIONAL INFORMATION AND/OR THE CVI INJECTION SYSTEM AND COMPLETION OF THE EVALUATION OF THESE ITEMS, ACIST WILL SUBMIT A FOLLOW-UP REPORT TO FDA.

    Description of Event or Problem · 1

    AIR WAS INJECTED INTO A PATIENT DURING A CORONARY ANGIOGRAPHY. PATIENT DEATH OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816635 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death