BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 25135693 · Received May 11, 2026

    Report

    Report Number
    3002808486-2026-00081
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 11, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    UDI-DI
    00827002454088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    Reporter Occupation
    OTHER

    Narratives

    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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR), RESISTANCE WAS ENCOUNTERED WHEN THE ZTA-PT-38-34-167-W1 WAS INSERTED OVER THE TSCMG-35-300-LESDC. THE TSCMG-35-300-LESDC WAS FLUSHED AGAIN; HOWEVER, THE ISSUE WAS NOT RESOLVED. THE GUIDEWIRE WAS THEN EXCHANGED FOR ANOTHER TSCMG-35-300-LESDC, AFTER WHICH THE ZTA-PT-38-34-167-W1 WAS ADVANCED WITHOUT RESISTANCE AND PLACED AT THE PLANNED LOCATION. A COATING ISSUE WITH THE COMPLAINT TSCMG-35-300-LESDC WAS SUSPECTED. PATIENT OUTCOME: NO HEALTH HAZARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279716 LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE G45408 E4717733 00827002454088

    Patients

    Seq Age Sex Outcome Treatment
    1