BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MICROWAVE DISPOSABLE

    MDR report key: 3010965 · Received March 15, 2013

    Report

    Report Number
    1717344-2013-00190
    Event Type
    Injury
    Date Received
    March 15, 2013
    Report Date
    March 14, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    NEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFO RECEIVED FROM PUBLISHED LITERATURE FROM AN INTERNATIONAL SYMPOSIUM ON ENDOVASCULAR THERAPY HELD ON JANUARY 19-23, 2013. THE LITERATURE INDICATED THAT A PT WITH PANCREATIC CANCER UNDERWENT A MICROWAVE ABLATION PERCUTANEOUSLY. ABLATION TIME WAS 10 MINUTES. A POST CLINICAL FOLLOW-UP STUDY FOUND THAT THE PT HAD AN ONSET OF ABDOMINAL PAIN 30 DAYS AFTER THE PROCEDURE HAD BEEN PERFORMED. A CT SCAN REVEALED THE PRESENCE OF DEVELOPED PSEUDOANEURYSM OF THE GASTRODUODENAL ARTERY THAT WAS TREATED WITH AN ENDOVASCULAR APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110692 UNK MICROWAVE DISPOSABLE MICROWAVE ABLATION ACCESSORY NEY COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other