BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 6506543 · Received April 20, 2017

    Report

    Report Number
    3002808486-2017-00953
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    March 28, 2017
    Report Date
    March 29, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    UDI-DI
    00827002453531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). A1) UNKNOWN AS INFORMATION WAS NOT PROVIDED. A2) UNKNOWN AS INFORMATION WAS NOT PROVIDED. A3) UNKNOWN AS INFORMATION WAS NOT PROVIDED. A4) UNKNOWN AS INFORMATION WAS NOT PROVIDED. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SIMILAR TO DEVICE UNDER 510(K): K061670. (B)(4). 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: DOCTOR FELT THE WIRE GUIDE GOT CAUGHT ON THE STENT GRAFT AND MADE A BURR ON THE WIRE AND THE WIRE THEN GOT CAUGHT IN THE CATHETER LUMEN. WHEN HE TRIED TO REMOVE THE WIRE IT UNRAVELLED IN THE CATHETER. HE WAS ABLE TO REMOVE IT SAFELY FROM THE PATIENT. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016032. (B)(4). MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS BASED ON THE EVENT DESCRIPTION AND THE RETURNED PRODUCT. TWO WIRE GUIDES WERE RETURNED AND IN BOTH THE SAFETY WIRE HAD SEPARATED IN THE TIP AND CONSEQUENTLY THE COIL PORTION HAD ELONGATED. HOWEVER, A SMALL REMAIN OF THE SAFETY WIRE IS CLEARLY VISIBLE IN THE WELDING JOINT, THUS DETERMINING CORRECT WELDING OF SAFETY WIRE TO FLEX TIP. THERE IS NO EVIDENCE TO SUGGEST THE WIRE GUIDE WAS NOT MANUFACTURED TO SPECIFICATIONS, BUT IT IS SUGGESTED THAT IT UNRAVELED DURING ATTEMPTED REMOVAL AFTER THE STENT GRAFT "MADE A BURR ON THE WIRE AND THE WIRE THEN GOT CAUGHT IN THE CATHETER LUMEN" AS REPORTED. NO EVIDENCE TO SUGGEST PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290803 LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE G45353 00827002453531

    Patients

    Seq Age Sex Outcome Treatment
    1