BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORX GUIDEWIRE

    MDR report key: 24258453 · Received February 4, 2026

    Report

    Report Number
    1649395-2025-00008
    Event Type
    Malfunction
    Date Received
    February 4, 2026
    Date of Event
    October 10, 2024
    Report Date
    February 4, 2026
    Manufacturer
    GALT MEDICAL CORP.
    Product Code
    DQX
    UDI-DI
    00841268101180
    PMA / PMN Number
    K021990
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DURING A LEG ANGIOGRAM HE USED AN SGW-038-07 (TORX .014 X 300CM) AND THE GOLD TIP CAME OFF OF THE WIRE AND WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323645 TORX GUIDEWIRE TORX GUIDEWIRE DQX GALT MEDICAL CORP. G23013196 00841268101180

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown