BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 9284976 · Received November 6, 2019

    Report

    Report Number
    2134243-2019-00019
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    August 31, 2019
    Report Date
    October 7, 2019
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SYSTEM SERIAL NUMBER (B)(4), WAS RECEIVED AT ACIST FOR EVALUATION ON (B)(6) 2019. THE INJECTION 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. THE CAUSE OF THE EVENT IS INCONCLUSIVE. THIS REPORT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    EVENT INFORMATION WAS RECEIVED BY ACIST MEDICAL SYSTEMS, INC., VIA A USER FACILITY MEDWATCH (REPORT NUMBER 2100490000-2019-8003) PROVIDED BY THE FDA. DURING A CARDIAC CATHETERIZATION PROCEDURE USING THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, AIR WAS INJECTED INTO THE PATIENT'S CORONARY ARTERY UPON THE THIRD INJECTION OF CONTRAST MEDIA. THE PATIENT EXPERIENCED HEMODYNAMIC DETERIORATION AND VENTRICULAR FIBRILLATION. THE PATIENT WAS RESUSCITATED AND INTERVENTION TO THE CORONARY ARTERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079858 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC. CVI

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R