BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 18787177 · Received February 27, 2024

    Report

    Report Number
    3002808486-2024-00042
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    February 1, 2024
    Report Date
    February 27, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). G4) PMA/510(K): K220137. SUMMARY OF INVESTIGATIONAL FINDINGS: DURING AN ENDO VASCULAR AORTIC REPAIR PROCEDURE THE WIRE GUIDE KINKED DURING ADVANCEMENT. THE WIRE GUIDE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER LUNDERQUIST WIRE WITHOUT REPORTED HARM TO THE PATIENT. THE WIREGUIDE WAS NOT RETURNED FOR ANALYSIS AND REPORTEDLY THE WIRE TIP WAS NOT ALTERED PRIOR TO USE, BUT BASED ON THE INFORMATION PROVIDED THE TORTUOSITY OF THE BLOOD VESSEL, WHICH ¿WAS STRONGER THAN EXPECTED¿ MAY HAVE CAUSED DIFFICULTIES IN ADVANCING THE WIRE GUIDE AND FOLLOWING UNINTENDED MANIPULATION/EXCESSIVE FORCE APPLIED DURING ADVANCEMENT CAUSED IT TO KINK. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT WAS ASSESSED THAT BECAUSE NO NON-CONFORMANCES WERE DETECTED, THERE IS EVIDENCE THAT THE DEVICE HISTORY RECORD 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 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.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PATIENT ANATOMY BEFORE SURGERY AND AT THE TIME OF FAILURE: USE WITHIN THE INDICATED RANGE. APPROACHED FROM THE RIGHT SIDE TO THE ABDOMEN. DURING AN ENDO VASCULAR AORTIC REPAIR CASE FOR AORTIC DISSECTION USING JAPAN LIFELINE/AFX AND A WIRE GUIDE (TERUMO/RADIFOCUS STICK TYPE J TYPE) WAS INSERTED FROM THE LEFT INGUINAL ARTERY TO INSERT AN 8FR SHEATH. THE TORTUOSITY OF THE BLOOD VESSEL WAS STRONGER THAN EXPECTED, SO LUNDERQUIST WAS PREPARED ON THE BACK TABLE AND INSERTED FROM THE SAME SPOT, BUT IT KINKED MIDWAY THROUGH, MAKING IT UNUSABLE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS BY USING ANOTHER TSCMG-35-260-7-LES (LOT# UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102770 LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE E4470596

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male