BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 6696365 · Received July 10, 2017

    Report

    Report Number
    3002808486-2017-01434
    Event Type
    Malfunction
    Date Received
    July 10, 2017
    Date of Event
    June 13, 2017
    Report Date
    June 15, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    UDI-DI
    00827002314535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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). 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.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE USER OPENED THE PACKAGE FOUND THAT THE FRONT END OF THE LUNDERQUIST WIRE GUIDE WAS RELEASING PATIENT OUTCOME: N/A - THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016032. (B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE WIRE GUIDE WAS RETURNED INSIDE ORIGINAL HOLDER. THE SAFETY WIRE WAS BROKEN AND APPROX. 5CM OF THE COILS HAD UNRAVELED. HOWEVER, A REMNANT OF THE SAFETY WIRE IN THE WELDING CLEARLY INDICATED A WELDING ACCORDING TO SPECIFICATIONS, IE THE COILS HAD BEEN PROPERLY ATTACHED TO THE SAFETY WIRE. THE HOLDER WAS CLEARLY CONTAMINATED, DESPITE REPORTED THAT THE DAMAGED WIRE GUIDE WAS DISCOVERED, WHEN "THE USER OPENED THE PACKAGE". BASED ON THESE FINDINGS IT IS SUGGESTED THAT THE WIRE GUIDE WAS EXPOSED TO MANIPULATION BEYOND ITS INTENDED DESIGN, MAYBE DURING ATTEMPTS TO CURVE THE WIRE DURING PREPARATION. NO EVIDENCE TO SUGGEST THAT THIS WIRE GUIDE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT IT DID NOT PERFORM AS INTENDED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478191 LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE G31453 00827002314535

    Patients

    Seq Age Sex Outcome Treatment
    1