BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 7078322 · Received December 4, 2017

    Report

    Report Number
    3002808486-2017-02309
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    November 9, 2017
    Report Date
    February 26, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    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). MANUFACTURERS 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: "BIB BALLOON WITH CP STENT DIFFICULT TO ADVANCE OVER THE WIRE. WHEN WIRE REMOVED IT APPEARED UNRAVELLED ABOUT 20 CM FROM THE J TIP. PROCEDURE WAS FOR MELODY VALVE IMPLANT". PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016032. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS BASED ON EVENT DESCRIPTION AND RETURNED PRODUCT. INVESTIGATION OF THE RETURNED WIRE GUIDE CONFIRMED THE REPORTED UNRAVELING APPROX. 20CM FROM THE DISTAL TIP; 2-3 COILS HAD UNRAVELED IN THE TRANSITION BETWEEN SHAFT AND COILED PORTION AND CAUSED THE REPORTED DIFFICULTIES IN ADVANCING BALLOON/STENT. THE EXACT REASON FOR THIS TO OCCUR CANNOT BE DETERMINED, BUT A PART OF THE COILED PORTION MAY UNRAVEL, IF ATTEMPTS ARE MADE TO TURN/MANIPULATE THE PROXIMAL PART OF THE WIRE GUIDE, WHILE THE DISTAL PART SOMEHOW STICKS AND DOES NOT TURN. NO EVIDENCE TO SUGGEST THAT THIS WIRE GUIDE 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
    858404 LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1