BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTION HYBRID WIRE GUIDE

    MDR report key: 23550458 · Received November 13, 2025

    Report

    Report Number
    3008988055-2025-00013
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    September 9, 2025
    Report Date
    January 27, 2026
    Manufacturer
    HERAEUS MEDICAL COMPONENTS LLC
    Product Code
    EZB
    UDI-DI
    00827002448469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT 3008988055-2025-00013 IS BEING AMENDED TO ADD THE CORRECT THE FDA CODING FOR INVESTIGATION FINDINGS.

    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 NOT RETURNED TO MANUFACTURER AND THE INVESTIGATION WAS CONCLUDED.

    Description of Event or Problem · 0

    IT WAS REPORTED "ON THE(B)(6) 2025 THE WIRE STARTED TO SHRED INSIDE THE PATIENT. PIECES OF TEFLON DETACHED INSIDE THE PATIENT AND HAD TO BE RETRIEVED WITH A BASKET. ALL PARTS WERE RETRIEVED. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED: WHEN DID THE EVENT OCCUR? (PRIOR TO USE, DURING INSERTION, DURING REMOVAL, ETC.) -UNKR PLEASE DESCRIBE THE ACCESS SITE WAS WELL AS THE TARGET LOCATION FOR USE OF THE WIRE. -URETHRA, BLADDER. DESCRIBE THE PATIENT'S ANATOMY AND DISEASE SEVERITY. (VESSEL, CALCIFICATION, TORTUOSITY, ANGULATION, ETC.)? -UNKR WAS THE WIRE ALTERED FROM ITS ORIGINAL CONDITION PRIOR TO USE? -UNKR, NO. WHAT IS THE PATIENT'S STATUS OR OUTCOME? -FINE. HAVE ANY KINDS OF INTERVENTION, ADDITIONAL PROCEDURES BEEN PERFORMED? -REMOVAL OF DEVICE FRAGMENTS. WHAT PRE-EXISTING CONDITIONS/CO-MORBIDITIES DID THE PATIENT HAVE? -UNKR. WHAT OTHER MEDICAL DEVICES WERE UTILIZED IN THIS CASE? PLEASE PROVIDE THE MANUFACTURER, BRAND, SIZE, AND PART NUMBER IF POSSIBLE. -UNKR. WAS THE WIRE ALTERED FROM ITS ORIGINAL CONDITION PRIOR TO USE? -UNKR. WAS ANY KINKING OF THE WIRE NOTED? (IF SO, ARE SHARP EDGES PRESENT) -NO. CAN PHOTOS OR VIDEO FROM THE PROCEDURE, (DURING AND/OR AFTER) OR OF THE DEVICE BE PROVIDED? -POSSIBLY. IS THE PATIENT TESTED POSITIVE TO ANY INFECTIOUS DISEASES? -UNK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249334 MOTION HYBRID WIRE GUIDE STYLET FOR CATHETER, GASTRO-UROLOGY EZB HERAEUS MEDICAL COMPONENTS LLC SP-4113-001 9019272681 00827002448469

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other