BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERSOFT 3D ADVANCED

    MDR report key: 20694311 · Received November 15, 2024

    Report

    Report Number
    20694311
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    August 27, 2024
    Report Date
    September 13, 2024
    Manufacturer
    MICROVENTION INC.
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    COIL WAS GETTING CAUGHT IN MICROCATHETER BEFORE DEPLOYMENT. MANUFACTURER RESPONSE FOR NEURO COIL, MICROVENTION INC (PER SITE REPORTER). ACCOUNT REP REQUESTED TO PICK UP THE DEFECTIVE DEVICE AND PROVIDE A NO CHARGE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143682 HYPERSOFT 3D ADVANCED DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICROVENTION INC. 8410-0208 0000617503

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male