BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EV3 NEUROVASCULAR MICROCATHETER

    MDR report key: 8842114 · Received July 23, 2019

    Report

    Report Number
    8842114
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    July 9, 2019
    Report Date
    July 22, 2019
    Product Code
    MFE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    APOLLO CATHETER UTILIZED DURING AVM EMBOLIZATION PROCEDURE MALFUNCTIONED AND ALLOWED TRU-FILL (GLUE) TO LEAK INTO THE PT'S MCA CAUSING AN OCCLUSION. DR (B)(6) ATTEMPTED TO PERFORM A THROMBECTOMY TO CORRECT THE MALFUNCTION BUT HAD LIMITED SUCCESS. TRU-FILL REMAINED IN THE PT'S MCA. HAVE NOT SENT THE DEVICE TO THE COMPANY AS OUR ORGANIZATION MAY DECIDE TO SEND TO AN INDEPENDENT COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613903 EV3 NEUROVASCULAR MICROCATHETER APOLLO ONYX DELIVERY MFE A822022

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| S