BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    MDR report key: 3417756 · Received October 15, 2013

    Report

    Report Number
    2522007-2013-00036
    Event Type
    Death
    Date Received
    October 15, 2013
    Date of Event
    September 11, 2013
    Report Date
    October 14, 2013
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DQX
    PMA / PMN Number
    K970690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO INFORMATION SUPPLIED TO TRACKWISE, THIS PRODUCT IS NOT BEING RETURNED FOR EVALUATION. AS THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    COOK IRELAND REPORTED FOR THE CUSTOMER, "DURING A LEAD EXTRACTION THE PATIENT GOT A HAEMATOTHORAX (HEMOTHORAX) BLEEDING. DUE TO THE BAD CONDITION OF THE PATIENT HE EXPIRED. COOK REP ATTENDED THE CASE." REP RESPONSE: "THIS COMPLICATION OCCURS IF YOU DAMAGE A VESSEL WITH A TOOL. IT COULD BE POSSIBLE WITH A WIRE, SHEATH, ETC. OR ONLY TROUGH SIMPLE TRACTION. ALL THESE MANEUVERS DR (B)(6) DID SO IT'S NOT POSSIBLE TO SAY WHAT THE REASON FOR THE BLEEDING WAS. THE BLEEDING IS A WELL KNOWN COMPLICATION WHICH THE PATIENTS ACCEPT BEFORE. THE COMPLETE BAD SITUATION (PRE REANIMATION) MADE THE OPERATION MORE DIFFICULT THAN USUAL. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE: ASPIRATION DRAINAGE. THE COMPLAINANT DID REPORT ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE: PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527925 LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET CATHETER GUIDE WIRE DQX COOK VASCULAR INC. LR-OFA01 N110406

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| L| R