BEUDAMED
    FDA Adverse Event Death Summary report: N

    COVIDIEN

    MDR report key: 1468848 · Received August 28, 2009

    Report

    Report Number
    1468848
    Event Type
    Death
    Date Received
    August 28, 2009
    Date of Event
    August 14, 2009
    Report Date
    August 26, 2009
    Manufacturer
    VALLEY LAB
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WE ARE WRITING TO INFORM THE FDA OF AN UNEXPECTED SERIOUS ADVERSE EVENT (SAE) WHICH RESULTED IN A PARTICIPANT DEATH IN 2009 THAT OCCURRED FOLLOWING THE USE OF A LEGALLY MARKETED DEVICE USED IN ACCORDANCE WITH ITS LABELING IN THE CONTEXT OF A RESEARCH STUDY. THE EVENT OCCURRED TWO WEEKS FOLLOWING THE PROCEDURE. THE PATIENT EXPIRED THAT DAY, FOLLOWING RADIOFREQUENCY ABLATION OF 2 PULMONARY NODULES TWO WEEKS PRIOR TO THE PT'S DEATH. THE PATIENT COUGHED AND DIED OF MASSIVE HEMOPTYSIS AT HOME. HIS CHEST WAS OPENED, BUT THE MEDIAL NECROTIC ABLATED NODULE HAD ERODED INTO A VESSEL AND BRONCHUS AND NOTHING COULD BE DONE. A MEDIAL 2 CM HEPATOBLASTOMA NODULE BRIDGING THE RML, RLL AND CONTIGUOUS WITH THE RML, RLL PULMONARY ARTERY AND BRONCHI WAS RF ABLATED WITH A 17G COOL TIP CLUSTER PROBE WITH 3, 2.5 CM ACTIVE TIPS. TWO, 12 MINUTE BURNS WERE PERFORMED THERE, ONE POSITION NEXT TO THE 4MM RLL BRONCHUS AND THE NEXT, NEXT TO THE 10MM RML PULMONARY ARTERY. THAT LESION HEATED REMARKABLY WELL TO 73 C WITHOUT INCREASING THE PATIENT'S CORE BODY TEMPERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN COOL-TIP RADIOFREQUENCY GENERATOR GEI VALLEY LAB CC-1-117

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Death