BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOL-TIP SINGLE ELEC 15CM X 3CM KIT

    MDR report key: 2032647 · Received March 22, 2011

    Report

    Report Number
    1717344-2011-00211
    Event Type
    Death
    Date Received
    March 22, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 3, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT DEVICE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVAL. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PERCUTANEOUS RF ABLATION PROCEDURE FOR PRIMARY LIVER TUMOR, THE PT PASSED AWAY DUE TO CARDIAC ARREST. THE TUMOR POSITION WAS S3 ON LIVER SURFACE JUST BELOW DIAPHRAGM. THE PT SUDDENLY DEPRESSED CONSCIOUSNESS AND HAD A CARDIAC ARREST. ACCUMULATED BLOOD WAS FOUND AND REMOVED FROM THE HEART BY DRAINAGE. BEFORE THIS SUDDEN EVENT, THE PT HAD NOTHING WRONG EXCEPT THE COMMON PAIN IN THE SHOULDERS AND NO ABNORMALITIES WERE OBSERVED IN THE DEVICES. THE ADMINISTRATIVE AUTOPSY FOUND A 1MM-HOLE AND BLEEDING ON THE DIAPHRAM, EPICARDIUM AND CARDIAC MUSCLE. ACCORDING TO THE MEDICAL EXAMINER, THERE SEEMS TO BE NO SIGN OF HEAT DENATURATION IN ORGAN DAMAGE. THE CAUSE OF THE PT'S DEATH IS STILL UNK AT THIS MOMENT. IT IS CURRENTLY BEING EXPECTED THAT IT WILL TAKE ONE YR UNTIL THE FINAL AUTOPSY REPORT IS SUBMITTED BY THE MEDICAL EXAMINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL-TIP SINGLE ELEC 15CM X 3CM KIT RF ABLATION ELECTRODE GEI COVIDIEN LP (VALLEYLAB) 175017

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death