BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTION HYBRID WIRE GUIDE

    MDR report key: 23086906 · Received September 18, 2025

    Report

    Report Number
    3008988055-2025-00009
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Report Date
    October 9, 2025
    Manufacturer
    HERAEUS MEDICAL COMPONENTS LLC
    Product Code
    EZB
    UDI-DI
    00827002448469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT THE DEVICE HAS MALFUNCTIONED OR THAT THE DEVICE WAS RELATED TO A DEATH OR INJURY. DEVICE WAS RETURNED TO MANUFACTURER AND THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE REPORT 3008988055-2025-00009 IS BEING AMENDED TO ADD THE CORRECT THE FDA CODING FOR INVESTIGATION FINDINGS AND CONCLUSIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED "A PATIENT OF UNDICLOSED GENDER AND AGE UNDEWENT AN UNSPECIFIED PROCEDURE IN WHISH THE MOTION HYBRID WIRE GUIDE, G44846 WAS USED. (B)(6) CENTER (C29022-0) CALLED TO SHARE A MOTION WIRE (G44846) LOT # 9019157405 HAD STRIPPED COATING LEAVING DEBRIS IN THE BLADDER. THE FIRST PHOTOS INCLUDED ARE OF THE PACKAGED AND PHOTOS TAKEN OF THE DEBRIS IN THE BLADDER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2802591 MOTION HYBRID WIRE GUIDE STYLET FOR CATHETER, GASTRO-UROLOGY EZB HERAEUS MEDICAL COMPONENTS LLC SP-4113-001 9019157405 00827002448469

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other