BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 16085022 · Received January 3, 2023

    Report

    Report Number
    3002808486-2023-00003
    Event Type
    Injury
    Date Received
    January 3, 2023
    Date of Event
    December 23, 2022
    Report Date
    February 14, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    UDI-DI
    00827002454088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SIMILAR TO DEVICE MARKETED UNDER 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

    MANUFACTURERS REF# (B)(4). AFTER INVESTIGATION THE EVENT FOR THIS PR# IS NO LONGER REPORTABLE. SUMMARY OF INVESTIGATIONAL FINDINGS: RESISTANCE WAS FELT, WHEN ADVANCING THE ZENITH DELIVERY WIRE. TWO DOCTORS HELD THE WIRE GUIDE TIGHTLY/FIRMLY AND PUSHED THE ZENITH DELIVERY SYSTEM WITH FORCE TO MANAGE TO ADVANCE IT TO THE TARGET SITE. ALSO, RESISTANCE WAS FELT, WHEN ADVANCING A SECOND ZENITH DEVICE OVER THE WIRE GUIDE AND THIS WAS PLACED BY FORCE, TOO. THE WIRE GUIDE WAS RETURNED INSIDE THE HOLDER, BUT AFTER REMOVAL AN INVESTIGATION FOUND THE WIRE GUIDE DIMENSIONS WITHIN SPECIFICATIONS, BUT REVEALED A MINOR ELONGATION NEXT TO THE WELDING. FOUR KINKS WERE NOTED ON THE WIRE GUIDE AND THE MOST DISTAL KINK 48MM FROM THE TIP, IS WHERE THE DOUBLE CURVE STARTS. THE DOUBLE CURVE HAD STRAIGHTENED, LIKELY DURING ATTEMPT TO ALTER THE TIP. BASED ON THESE FINDINGS THE EXACT REASON FOR THE DIFFICULTIES IN ADVANCING THE FIRST ZENITH DELIVERY SYSTEM OVER THE WIRE GUIDE CANNOT BE DETERMINED. HOWEVER, THE MOST DISTAL KINK CLOSE TO THE STRAIGHTENED CURVE MAY HAVE BEEN UNINTENDEDLY ADDED DURING ATTEMPTS TO ALTER THE TIP CONFIGURATION PRIOR TO USE AND MAY HAVE CAUSED THE DIFFICULTIES ENCOUNTERED. FOLLOWING, THE DIFFICULTIES IN ADVANCING THE FIRST ZENITH DEVICE MAY HAVE CAUSED FURTHER DAMAGE TO THE WIRE GUIDE, WHICH AGAIN CAUSED THE DIFFICULTIES IN ADVANCING THE SECOND ZENITH DEVICE. 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. 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: PHYSICIAN ATTEMPTED TO DELIVER ZTA-P-34-161-W1 TO TARGET SITE AT THE ARCH AORTA OVER LUNDERQUIST TSCMG-35-300-LESDC APPROACHING FROM RIGHT CFA, HE FELT THE RESISTANCE OF SCRAPING AND DIFFICULTY IN ADVANCING THE DELIVERY SYSTEM. THEREFORE HE FIXED A WIRE GUIDE WITH ANOTHER PHYSICIAN AND PUSHED AND ADVANCED BY FORCE TO PLACE IT. WHEN THEY ATTEMPTED TO PLACE ZTA-DE-34-112-W1, THEY ALSO FELT SAME DIFFICULTY AND PLACED BY FORCE. THERE WAS A ABNORMALITY ABOUT 10 CM FROM THE TIP. IT SEEMED THAT THERE WAS A DEFECT OF COATING OF WIRE GUIDE OR COIL. PATIENT OUTCOME: NO HEALTH HAZARD.

    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
    653312 LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE G45408 E3899874 00827002454088

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male