BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN COOL TIP ELECTRODE

    MDR report key: 3371500 · Received September 23, 2013

    Report

    Report Number
    1717344-2013-00749
    Event Type
    Death
    Date Received
    September 23, 2013
    Report Date
    August 27, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE WAS NOT RETURNED TO COVIDIEN FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE INCIDENT WAS IDENTIFIED FROM A REVIEW OF LITERATURE IN THE JOURNAL OF SURGICAL ONCOLOGY 2006; 94: 392-395 HIGH OPERATIVE RISK OF COOL-TIP RADIOFREQUENCY ABLATION FOR UNRESECTABLE PANCREATIC HEAD CANCER. SIXTEEN PTS WERE TREATED DURING OCTOBER 2003 - JULY 2004. THE PT, WITH A TUMOR CLOSE TO THE PORTAL VEIN, DIED SUDDENLY OF MASSIVE GASTROINTESTINAL HEMORRHAGE ON THE 4TH POSTOPERATIVE DAY. PORTAL VEIN THROMBOSIS (PVT) HAD BEEN FOUND AFTER THE RF ABLATION NEAR THE MAIN PORTAL VEIN WITH PRINGLE'S MANOEUVRE, WHICH RESULTED FROM RADIOFREQUENCY HYPERTHERMIA. THE PORTAL HYPERTENSION RESULTING FROM PVT WAS VERY LIKELY THE CAUSE OF THE MASSIVE GASTROINTESTINAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479611 UNKNOWN COOL TIP ELECTRODE RF ABLATION ELECTRODE GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death