BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC PERIPHERAL (FORMERLY COVIDIEN VASCULAR EV3) GUIDEWIRE

    MDR report key: 22913209 · Received August 28, 2025

    Report

    Report Number
    MW5175324
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    May 12, 2025
    Report Date
    August 21, 2025
    Manufacturer
    MEDTRONIC/COVIDIEN LP
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GUIDE WIRE USED IN INTERVENTIONAL RADIOLOGY CASE IS SUSPECTED TO HAVE LEFT A WIRE FRAGMENT BEHIND IN PATIENT RESULTING IN RETAINED FOREIGN OBJECT. THERE ARE MULTIPLE GUIDE WIRES USED AND IT IS IMPOSSIBLE TO KNOW WHICH ONE IT WAS. THE SAME THING HAPPENED TO THE SAME PATIENT ON A DIFFERENT INTERVENTIONAL RADIOLOGY CASE ON JULY 11. WIRE FRAGMENTS WERE NOT REMOVED BECAUSE IT IS NOT IN THE BEST INTEREST OF THE PATIENT TO REMOVE AT THIS TIME WE PULLED THE LOTS OF WIRES INVOLVED IN CASE IT IS NEEDED AND TO MAKE SURE NO PATIENTS RECEIVED WIRES FROM THOSE LOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2163998 MEDTRONIC PERIPHERAL (FORMERLY COVIDIEN VASCULAR EV3) GUIDEWIRE WIRE, GUIDE, CATHETER DQX MEDTRONIC/COVIDIEN LP N180601 9326797

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other BOSTON SCIENTIFIC GUIDE WIRE.| COOK GUIDE WIRE.| TERUMO GUIDE WIRE.