BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC EV3 APOLLO ONYX DELIVERY MICRO CATHETER

    MDR report key: 20002757 · Received August 19, 2024

    Report

    Report Number
    MW5158628
    Event Type
    Injury
    Date Received
    August 19, 2024
    Date of Event
    August 9, 2024
    Report Date
    August 15, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN USING THE MEDTRONIC APOLLO ONYX MICROCATHETER 105-5095-000, LOT B558628, THE CATHETER FILTER DEPLOYED PRIOR TO REACHING ITS TARGETED DESTINATION. THE DETACHABLE TIP PORTION OF THE CATHETER DETACHED FROM THE CATHETER EARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2361900 MEDTRONIC EV3 APOLLO ONYX DELIVERY MICRO CATHETER AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR B558629

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other