BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTION HYBRID WIRE GUIDE

    MDR report key: 23390185 · Received October 27, 2025

    Report

    Report Number
    23390185
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    September 18, 2025
    Report Date
    October 2, 2025
    Manufacturer
    HERAEUS MEDICAL COMPONENTS LLC
    Product Code
    EZB
    UDI-DI
    00827002448469
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GUIDEWIRE BROKE WHILE INSIDE PATIENT WHEN USING LASER. SURGEON REMOVED THE BROKEN PIECES. POTENTIAL ISSUE WITH LASER HITTING GUIDEWIRE CAUSING BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2733957 MOTION HYBRID WIRE GUIDE STYLET FOR CATHETER, GASTRO-UROLOGY EZB HERAEUS MEDICAL COMPONENTS LLC MHW-035150 9019157405 00827002448469

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male