BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION SHORTIE MECHANICAL DILATOR SHEATH

    MDR report key: 1523106 · Received November 5, 2009

    Report

    Report Number
    2522007-2009-00010
    Event Type
    Death
    Date Received
    November 5, 2009
    Date of Event
    September 30, 2009
    Report Date
    October 20, 2009
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DRE
    PMA / PMN Number
    K061000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED COPY OF AUTOPSY REPORT, FOR FURTHER EVAL. PRODUCT NOT BEING RETURNED FOR EVAL. PRODUCT WAS DISPOSED.

    Description of Event or Problem · 1

    THE CARDIOLOGIST WANTED TO REMOVE A 29 YEAR OLD 9F VENTRICLE LEAD WITH PASSIVE FIXATION. AFTER DRESSING THE LEAD, THE LIBERATOR SHE ENTERED THE VESSEL SUCCESSFULLY WITH THE 11.5 BYRD DILATOR. THERE WAS A LOT OF FIBROSIS AND SHE PROCEEDED WITH AN 11 F SHORTIE AND PASSED THE SUBCLAVIA WITH SUCCESS. THE NEXT STEP WAS THE USE OF THE 11 F EVOLUTION. AFTER A CERTAIN POINT, SHE BROKE THE LEAD. SHE TRIED TO CATCH THE DISTAL PART WITH THE 11F BYRD DILATOR WITHOUT SUCCESS. SUDDENLY, THE PT HAD HEMODYNAMIC INSTABILITY WITH A COLLAPSE. REANIMATION STARTED IMMEDIATELY. AFTER 45 MINUTES THEY STOPPED REANIMATION, AND THE PT DIED. AT THAT MOMENT THERE WAS NO SPECIFIC REASON TO GIVE WHY THIS HEMODYNAMIC INSTABILITY HAPPENED. IT WAS NOT POSSIBLE TO SAVE THE PRODUCTS DURING AND AFTER THE REANIMATION AND IN MY OPINION, THIS EVENT IS NOT RELATED TO OUR PRODUCT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD EXTRACTION EVOLUTION SHORTIE MECHANICAL DILATOR SHEATH VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC. LR-EVN-SH-11.0 N78250

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death| L| R| S