BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEADWAY DUO MICROCATHETER

    MDR report key: 12418359 · Received September 2, 2021

    Report

    Report Number
    2032493-2021-00357
    Event Type
    Injury
    Date Received
    September 2, 2021
    Date of Event
    July 2, 2021
    Report Date
    August 4, 2021
    Product Code
    DQO
    PMA / PMN Number
    K120917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A SEARCH FOR PRODUCTION-RELATED NCRS COULD NOT BE PERFORMED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC. WILL ISSUE A SUPPLEMENTAL MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER ONYX LIQUID EMBOLIC AGENT WAS INJECTED INTO THE MIDDLE MENINGEAL ARTERY (MMA) TO EMBOLIZE THE VESSEL, THE TIP OF THE MICROCATHETER BROKE INSIDE THE BRANCH OF EXTERNAL ARTERY (RIGHT MMA) DURING ITS REMOVAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED. (REF UF MEDWATCH REPORT# (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315290 HEADWAY DUO MICROCATHETER DIAGNOSTIC INTRAVASCULAR CATHETER DQO MC162156S

    Patients

    Seq Age Sex Outcome Treatment
    1