BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEADWAY-DUO 16

    MDR report key: 16502783 · Received March 8, 2023

    Report

    Report Number
    2032493-2023-00602
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Report Date
    February 20, 2023
    Manufacturer
    MICROVENTION, INC.
    Product Code
    DQO
    PMA / PMN Number
    K120917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AT THE USER FACILITY AND NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. PROCEDURAL OR MEDICAL IMAGING WAS NOT PROVIDED. THE BREAKAGE ISSUE COULD NOT BE CONFIRMED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES CATHETER BREAKAGE AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL MDR REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIANS HAD PREVIOUS CASES OF THE TIP OF THE HEADWAY IN EMBOLIZATIONS WITH ONYX. NO LOT OR MODEL OR ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790503 HEADWAY-DUO 16 ACCESS DEVICES DQO MICROVENTION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other