BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 22975904 · Received September 5, 2025

    Report

    Report Number
    3002808486-2025-00194
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 29, 2025
    Report Date
    February 5, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    UDI-DI
    10827002454085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF # (B)(4). G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K220137 INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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

    MANUFACTURER¿S REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE LUNDERQUIST WIRE GUIDE FRAYED AFTER STICKING INSIDE THE DILATOR AND DIFFICULTIES IN REMOVING IT. THE TAVI PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER WIRE GUIDE WITHOUT CLINICAL CONSEQUENCES FOR THE PATIENT. THE COMPLAINT REPORTED BY THE USER WAS CONFIRMED. THE COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE EVALUATION DETERMINED FOLLOWING: NO BIOLOGICAL MATTER WAS OBSERVED ON THE WIRE GUIDE. DISTALLY THE MANDRIL INSIDE HAD FRACTURED CLOSE TO THE WELDING AND RESULTED IN SEVERE ELONGATION. THE MANDRIL WAS NO LONGER CURVED, BUT HAD NEARLY STRAIGHTENED. THE OUTER DIAMETER WAS FOUND WITHIN SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS AND/OR SPECIFICATIONS DID NOT REVEAL ANY DISCREPANCIES/NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE INVESTIGATION CONCLUDES THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION. THE REVIEW OF THE RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE HAS NOT PREVIOUSLY OCCURRED FOR THIS MANUFACTURING LOT. PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE AND/OR LABEL. A DEFINITIVE CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION. POSSIBLE CAUSES ARE DAMAGE DURING TIP ALTERATION/INCOMPATIBILITY WITH THE UNKNOWN DILATOR. AN INTERNAL ACTION IS NOT DEEMED NECESSARY AT THIS TIME. TRENDING WILL MONITOR IF ANY FUTURE ACTIONS ARE REQUIRED. AFTER CONSIDERING THIS EVENT THE RISK ASSOCIATED WITH THE USE OF THIS DEVICE IS STILL DEEMED ADEQUATE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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: ON (B)(6) 2025, IN THE INTERVENTIONAL CARDIOLOGY ROOM, DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, IT WAS NOTED THAT THE GUIDE REMAINED STUCK IN THE DILATOR, CAUSING DIFFICULTIES IN REMOVAL, CAUSING THE GUIDE TO COMPLETELY FRAY. THIS INCIDENT COULD HAVE RESULTED IN LOSS OF THE SURGICAL APPROACH OR EVEN EMBOLIZATION. A DEVICE OF THE SAME REFERENCE AND UNKNOWN LOT WAS USED TO CONTINUE THE PROCEDURE. PATIENT OUTCOME: THE 81-YEAR PATIENT SUFFERED NO CLINICAL CONSEQUENCES.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306400 LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE G45408 E4515748 10827002454085

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Unknown