BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORAYGUIDE GUIDEWIRE

    MDR report key: 22166853 · Received June 9, 2025

    Report

    Report Number
    22166853
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    April 29, 2025
    Report Date
    June 3, 2025
    Manufacturer
    TORAY INDUSTRIES (AMERICA), INC.
    Product Code
    DQX
    UDI-DI
    04960685200781
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    OUTPATIENT ARRIVED TO EP [ELECTROPHYSIOLOGY] LAB FOR PLANNED AFIB/ AFLUTTER [ATRIAL FIBRILLATION/ATRIAL FLUTTER] ABLATION. DURING TRANSSEPTAL ACCESS, TORAY GUIDEWIRE WAS REMOVED AND NOTED TO HAVE TIP BROKEN. MD ABLE TO VISUALIZE BROKEN TIP LODGED IN SEPTUM UNDER FLUOROSCOPY. CONSULT TO STRUCTURAL HEART TEAM. WIRE LEFT IN PLACE IN SEPTUM. ADDITIONAL PROCEDURE PERFORMED (AMPLATZER SEPTAL OCCLUDER DEVICE IMPLANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1633037 TORAYGUIDE GUIDEWIRE WIRE, GUIDE, CATHETER DQX TORAY INDUSTRIES (AMERICA), INC. TRG-25175 241205 04960685200781

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male