BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 11998293 · Received June 15, 2021

    Report

    Report Number
    3002808486-2021-01346
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    June 10, 2021
    Report Date
    October 22, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    UDI-DI
    00827002454088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A NON-COOK STENT GRAFT COULD NOT BE ADVANCED OVER THE WIRE GUIDE. THE WIRE WAS REMOVED AND THE STENT GRAFT WAS SUCCESSFULLY ADVANCED OVER ANOTHER LUNDERQUIST WIRE GUIDE. NO PRODUCT WAS RETURNED FOR ANALYSIS AND WITHOUT THE ACTUAL COMPLAINT DEVICE IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE ADVANCEMENT DIFFICULTIES ENCOUNTERED. DURING THE MANUFACTURING PROCESSES THE OUTER DIAMETER OF ANY WIRE GUIDE IS INSPECTED TO MEET SPECIFIED REQUIREMENTS. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE FINAL RELEASE, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. 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

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

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K171513. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORTER: TEVAR WAS PERFORMED AND THE WIRE GUIDE WAS INSERTED IN THE BODY. THE USER TRIED TO ADVANCE A GORE'S CTAG 40MMX15MM ((B)(4)) OVER THE WIRE BUT THE WIRE COULD NOT BE INSERTED AT ALL. THE USER THOUGHT THAT THE PROBLEM WAS EITHER THE SIZE OF THE WIRE OR THE WIRE LUMEN OF THE CTAG, THE LUNDERQUIST WAS REPLACED FIRST, AND AFTER ANOTHER LUNDERQUIST WAS PLACED, THE CTAG PASSED THROUGH, SO IT WAS CONCLUDED THAT THE PROBLEM WAS ON THE FIRST WIRE GUIDE. THE CTAG WAS PLACED AND THE PROCEDURE WAS COMPLETED. PATIENT OUTCOME: THE INITIAL REPORTER HAS NOT REPORTED ANY ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899372 LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE G45408 E4086543 00827002454088

    Patients

    Seq Age Sex Outcome Treatment
    1