BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 7793654 · Received August 17, 2018

    Report

    Report Number
    2134243-2018-00019
    Event Type
    Injury
    Date Received
    August 17, 2018
    Date of Event
    June 19, 2018
    Report Date
    October 2, 2018
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K010390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 THE ACIST ANGIOGRAPHIC INJECTION SYSTEM USED DURING THE EVENT BE RETURNED TO ACIST FOR EVALUATION AND REQUESTED ADDITIONAL INFORMATION ON THE EVENT. TO DATE, THE INJECTION SYSTEM HAS NOT BEEN RETURNED TO ACIST AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. EVALUATION IS PENDING.

    Description of Event or Problem · 1

    REPORTED BY ACLST CLINICAL SPECIALIST: DISSECTION OF PATIENT'S ARTERY DURING CARDIAC CATHETERIZATION. THE EVENT OCCURRED APPROXIMATELTY ONE MONTH BEFORE THE ACIST CLINICAL SPECIALIST BECAME AWARE OF THE EVENT. PATIENT'S CONDITION AFTER THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635243 ACIST INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening