BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 6334949 · Received February 16, 2017

    Report

    Report Number
    3002808486-2017-00479
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Date of Event
    July 14, 2016
    Report Date
    July 15, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    UDI-DI
    00827002348455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG# TSCMG-35-300-LESDC-JP. SIMILAR TO DEVICE UNDER 510(K) K061670. SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS BASED ON THE LIMITED INFORMATION PROVIDED ONLY. SINCE NO PRODUCT WAS RETURNED AND NO IMAGING WAS PROVIDED IT IS VERY DIFFICULT TO COMMENT ON THE RESISTANCE, WHICH WAS MET WHEN REMOVING THE DELIVERY SYSTEM, BECAUSE "SOMETHING GET LODGED" OR WHY RESISTANCE WAS MET, WHEN THE WIRE GUIDE WAS RE-INSERTED. ALSO, IT IS DIFFICULT TO COMMENT ON THE COMPATIBILITY BETWEEN THE NON COOK STENT GRAFT AND THE WIRE GUIDE. THERE IS NO EVIDENCE TO SUGGEST PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE WAS USED FOR TEVAR WITH OTHER MANUFACTURER'S STENT GRAFT (MEDTRONIC'S VALIANT : (B)(4)). THERE WAS NO PROBLEM WITH ADVANCING THE DELIVERY SYSTEM OVER IT AND DEPLOYMENT OF THE STENT GRAFT, BUT RESISTANCE WAS MET AS 'SOMETHING GET LODGED' WHEN REMOVING THE DELIVERY SYSTEM AND THE WIRE GUIDE CAME OUT WITH THE DELIVERY SYSTEM. HE FELT A RESISTANCE AGAIN WHEN HE REINSERTED THE WIRE GUIDE, SO HE REMOVED AND REPLACED IT WITH ANOTHER LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE. THE REPLACEMENT HAD NO PROBLEM AND THE PROCEDURE WAS COMPLETED. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118908 LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE 00827002348455

    Patients

    Seq Age Sex Outcome Treatment
    1