BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION MECHNICAL DILATOR SHEATH SET

    MDR report key: 2587455 · Received May 21, 2012

    Report

    Report Number
    2522007-2012-00006
    Event Type
    Death
    Date Received
    May 21, 2012
    Date of Event
    May 3, 2012
    Report Date
    May 16, 2012
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DRE
    PMA / PMN Number
    K061000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    WILLIAM COOK (B)(4) REPORTED FOR THE CUSTOMER, "AFTER PACEMAKER POCKET DEBRIDEMENT FIRST CHECK WITH THE NORMAL STYLET IF THE LUMEN OF THE LEAD IS CLEAR OR NOT THEN LOCK THE DISTAL TIP OF LEAD THROUGH COOK LIBERATOR LOCKING STYLET (LR-OFA01) THEN OVER THE LIBERATOR OVER THE LEAD PHYSICIAN USED 11FR EVOLUTION (LR-EVN-11.0) AND CROSSED THROUGH SVC TILL THE TIP OF LEAD AND SUCCESSFULLY EXTRACTED THE LEAD BUT JUST AFTER DETACHMENT OF LEAD TIP FROM THE RV APEX PRESSURE STARTED FALLING DOWN SO PHYSICIAN CAME INTO ACTION AND INSERTED A CATHETER NEAR PERICARDIUM TO DRAIN THE BLOOD AS WITH THE THOUGHT THAT THERE IS PERICARDIAL EFFUSION WHICH MAY LEAD TO CARDIAC TAMPONADE BUT WITH THE DRAINED FLUID IT WAS NOT LIKE THAT SO HE INJECTED DYE AND SAW THAT ACTUAL TEAR IS NEAR THE SVC JUNCTION THEN HE TRIED TO INSERT A INTRAVENOUS BALLOON BUT NOT ABLE TO DO THAT AS IT WAS TOO LATE TO TAKE THE ACTION, UNFORTUNATELY PT HEART HAD STOPPED TO DO ANY MOVEMENT." NO PART OF THE DEVICE REMAINED INSIDE THE PT. BECAUSE OF THE TEAR NEAR THE SVC JUNCTION, THE PT REQUIRED CATHETER INSERTION NEAR PERICARDIUM, THEN INTRAVENOUS BALLOON. THE PT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD EXTRACTION EVOLUTION MECHNICAL DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC. LR-EVN-11.0 N91248

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR