BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 24649294 · Received March 20, 2026

    Report

    Report Number
    3002808486-2026-00046
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    March 2, 2026
    Report Date
    May 20, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    UDI-DI
    00827002314535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF # (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): 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: INSERT THE 6F MERIT ARTERY SHEATH, ADVANCE THE STANDARD LOACH WIRE GUIDE ALONG THE SHEATH UNTIL IT REACHES THE ASCENDING AORTA, THEN REPLACE IT WITH N5.0-35-100-P-10S-PIG-CSC-20 FOR ANGIOGRAPHY. SWITCH TO TSMG-35-260-LES AND ADVANCE IT TO THE AORTIC SINUS. THE PROXIMAL END OF THE WIRE GUIDE BECAME BENT, SO IMMEDIATELY REPLACE IT WITH N5.0-35-100-P-10S-PIG-CSC-20 AND SWITCH TO A NEW TSMG-35-260-LES FOR PROCEDURE. PATIENT OUTCOME THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232874 LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE G31453 E4781674 00827002314535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown