BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 6964180 · Received October 20, 2017

    Report

    Report Number
    3002808486-2017-02057
    Event Type
    Death
    Date Received
    October 20, 2017
    Report Date
    September 24, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    PMA / PMN Number
    K061670
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    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). AFTER INVESTIGATION THE EVENT FOR THIS PR# IS NO LONGER REPORTABLE. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: NO PRODUCT WAS RETURNED AND NO IMAGING WAS PROVIDED. ALSO, AUTOPSY REPORT WAS REQUESTED, BUT NOT PROVIDED. IT IS REPORTED THAT THE COOK GUIDE WIRE WAS "USED FOR THE WORKING WIRE" AND APPARENTLY, IT WAS PLACED IN INTENDED LOCATION PRIOR TO DEPLOYING THE "29EVR" AND TO CHANGING TO A "34EVR". IT IS NOTED THAT THERE IS NO INFORMATION PROVIDED AS TO ANY FAILURE MODE RELATED TO THE GUIDE WIRE. ON THE CONTRARY, ACCORDING TO THE PHYSICIAN "THE WIRE WAS NOT TO BLAME, AS THE PROCEDURE TOOK WAY TOO LONG." BASED ON INFORMATION PROVIDED THE REPORTED INCIDENT IS CONSIDERED PROCEDURALLY RELATED AND OF NO FAULT TO THE COOK GUIDE WIRE. HOWEVER, THE COMPLAINT WILL BE REOPENED, IN CASE ADDITIONAL INFORMATION IS PROVIDED. NO EVIDENCE TO SUGGEST THAT THIS GUIDE WIRE 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.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "THE PATIENT WAS UNDERGOING TAVR VIA RFA WITH 29EVOLUTR. A DOUBLE CURVE LUNDERQUIST WIRE WAS BEING USED FOR THE WORKING WIRE. THE PHYSICIAN, ATTEMPTED TO DEPLOY THE 29EVR AND HAD POP OUT ON BOTH ATTEMPTS. AT THAT POINT, THE PHYSICIAN SELECTED TO CHANGE TO A 34EVR WHICH WOULD GIVE MORE RADIAL STRENGTH TO HELP THE VALVE STAY IN PLACE. A 34MM VALVE WAS PREPPED AND INTRODUCED. AS THE 34EVR WAS ADVANCED ACROSS ANNULUS, HOWEVER, PRIOR TO FULL DEPLOYMENT, THE PATIENT LOST PRESSURE. THE VALVE WAS SUBSEQUENTLY FULLY RECAPTURED AND PULLED OUT OF ANNULAR POSITION." PATIENT OUTCOME: THE PATIENT WAS PLACED ON CPS AND PERICARDIOCENTESIS WAS PERFORMED DUE TO TAMPONADE WHICH WAS CONFIRMED BY TEE. THE PATIENT EXPIRED SHORTLY THEREAFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744517 LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death