BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST CVI

    MDR report key: 6637212 · Received June 13, 2017

    Report

    Report Number
    6637212
    Event Type
    Malfunction
    Date Received
    June 13, 2017
    Date of Event
    May 22, 2017
    Report Date
    June 12, 2017
    Manufacturer
    ACIST MEDICAL SYSTEMS
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ON CATH LAB TABLE FOR STEMI; AFTER PLACING STENTS AND BALLOONS IN LAD, CARDIOLOGIST REQUESTED A POST-STENT INJECTION AT THE CORONARY ARTERY. THE TECH ATTEMPTED TO INJECT CONTRACT FROM HAND CONTROL OF ACIST AND RECEIVED NO CONTRAST; MESSAGE ON SCREEN: "MOTOR INSUFFICIENCY," IT APPEARED THAT THE DEVICE WAS LOCKED - COULD NOT PURGE OR INJECT; USED MANIFOLD KIT TO MANUALLY INJECT CONTRAST TO COMPLETE THE CASE. UNABLE TO SHOOT PICTURES OF CORONARIES FOR 210 MINUTES D/T THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419130 ACIST CVI ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS EP0014545

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other