BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN GENERATOR

    MDR report key: 8245775 · Received January 14, 2019

    Report

    Report Number
    1717344-2019-00085
    Event Type
    Death
    Date Received
    January 14, 2019
    Date of Event
    June 6, 2015
    Report Date
    February 13, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    OCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: MAJOR COMPLICATIONS OF HIGH-ENERGY MICROWAVE ABLATION FOR PERCUTANEOUS CT-GUIDED TREATMENT OF LUNG MALIGNANCIES: SINGLE-CENTRE EXPERIENCE AFTER 4 YEARS. SOURCE: JOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY, 59 (10), (609-616), 2015. DATE OF PUBLICATION: 06 JUN 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN REASSESSED AND FOUND TO BE A NON-MDR REPORTABLE COMPLAINT. THE ISSUE BEING REPORTED IS NOT ASSOCIATED WITH A SERIOUS INJURY OR POTENTIAL FOR SERIOUS INJURY WITH REOCCURRENCE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PLI-10: ACCORDING TO THE LITERATURE SOURCE PERFORMED FROM MAY 2010 TO SEPTEMBER 2014 , AFTER BEING TREATED WITH PERCUTANEOUS COMPUTED TOMOGRAPHY (CT)-GUIDED MICROWAVE ABLATION (MWA) OF PRIMARY AND SECONDARY LUNG MALIGNANCIES. THE PATIENT SUFFERED FROM PNEUMOTHORAX, LARGE EFFUSION, PULMONARY HEMORRHAGE, INFECTION, CHEST WALL BURN AND PLEURAL SEEDING. THEY USED THE EVIDENT¿ SYSTEM OPERATING AT 915 MHZ WITH MAXIMUM POWER OUTPUT OF 45 W, AND 13G ANTENNAE WITH A 2 CM OR A 3.7 CM ACTIVE TIP. FOR THE REMAINING 62 CASES (88.6% OF PATIENTS) THEY USED A HIGHER POWERED ACCULIS MICROWAVE TISSUE ABLATION SYSTEM (ANGIODYNAMICS), OPERATING AT 2.45 GHZ WITH A MAXIMUM POWER OUTPUT OF 140 W (POWER APPLIED WAS 80 W TO 120 W). PLI-20: ACCORDING TO THE LITERATURE SOURCE PERFORMED FROM MAY 2010 TO SEPTEMBER 2014, AFTER BEING TREATED WITH MICROWAVE ABLATION FOR SINGLE, FOCAL HEPATIC MALIGNANCIES, PATIENT SUFFERED DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39486 UNKNOWN GENERATOR ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN MFG DC BOULDER UNKNOWN GENERATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death