BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTION HYBRID WIRE GUIDE

    MDR report key: 23531733 · Received November 12, 2025

    Report

    Report Number
    23531733
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    September 9, 2025
    Report Date
    September 10, 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

    TIP OF A COOK WIRE USED FOR STENT PLACEMENT BROKE OFF INSIDE OF THE PATIENT DURING PROCEDURE. THE SURGEON REMOVED THE TIP OF THE COOK WIRE FROM THE PATIENT, REPORTED THE INCIDENT TO THE COOK INDUSTRY REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934171 MOTION HYBRID WIRE GUIDE STYLET FOR CATHETER, GASTRO-UROLOGY EZB HERAEUS MEDICAL COMPONENTS, LLC MHW-035150 9019244136 00827002448469

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female