BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROVENTION HEADWAY DUO STRONG

    MDR report key: 23019102 · Received September 10, 2025

    Report

    Report Number
    MW5175891
    Event Type
    Other
    Date Received
    September 10, 2025
    Date of Event
    August 16, 2025
    Report Date
    September 5, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    DQO
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT LEFT MIDDLE MENINGEAL ARTERY EMBOLIZATION FOR TREATMENT OF SUBDURAL HEMATOMA WITH MIDLINE SHIFT. DURING THE EMBOLIZATION PROCEDURE THE CATHETER TIP BECAME STUCK IN THE N-BUTYL CYANOACRYLATE EMBOLIZATION AGENT. THE TIP OF THE MICROCATHETER TIP WAS RETAINED WITHIN THE DISTAL LEFT PARIETAL BRANCH OF MIDDLE MENINGEAL ARTERY. THE PHYSICIAN HAS COMPLETED THIS PROCEDURE WITH THIS EMBOLIC AGENT AND MICROCATHETER WITH NO PROBLEMS PREVIOUSLY. NO DIFFERENCES IN TECHNIQUE OCCURRED PER THE PROVIDER. CATHETER: MICROVENTION HEADWAY DUO STRONG; 167 CENTIMETERS, REF# (B)(4), LOT: 0001103937. GLUE: CERENOVUS TRUFILL N-BUTYL CYANOACRYLATE REF#: (B)(4), LOT: M95M37.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2706857 MICROVENTION HEADWAY DUO STRONG CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MICROVENTION, INC. MC162167S 0001103937

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other CERENOVUS TRUFILL N-BCA REF#: (B)(4), LOT: M9571J. THERAPY START AND END DATE: