BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 23656227 · Received November 26, 2025

    Report

    Report Number
    3002808486-2025-00246
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 18, 2025
    Report Date
    November 26, 2025
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    UDI-DI
    00827002453531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF# ADDITIONAL INFORMATION RECEIVED ON 24NOV2025 CONFIRMS THAT THE SAME LOT NUMBER IS PRESENT IN BOTH (B)(4) AND (B)(4). THE INVESTIGATION WILL THEREFORE BE MANAGED UNDER (B)(4), AND THIS EVENT IS CONSEQUENTLY NO LONGER REPORTABLE THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4) BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) SIMILAR TO DEVICE MARKETED UNDER 510(K)/PMA: K220137 INVESTIGATION IS STILL IN PROGRESS THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WHILE CLEANING THE LUNDERQUIST DURING EVAR PROCEDURE, THERE APPEARS TO BE GREY SLUDGE LEFT BEHIND. COLLEAGUES HAVE CONFIRMED THAT THIS WAS ALSO NOTICED IN PREVIOUS PROCEDURES (THIS COMPLAINT, (B)(4). ON INSPECTION OF THE WIRE GUIDE IT LOOKS LIKE THERE ARE PATCHES WHERE THE COATING IS GONE AND THE WIRE GUIDE FEELS ROUGH OR RIGID (RELATED COMPLAINT, (B)(4). THE WIRE SEEMS TO HAVE SCRAPINGS OF THE TEFLON COATING COMING OFF. THEY USED THE WIRE THE ENTIRE PROCEDURE SO NO NEED FOR ADDITIONAL WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148585 LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE G45353 E4753105 00827002453531

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown