BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUWAVE

    MDR report key: 9503398 · Received December 20, 2019

    Report

    Report Number
    3008769756-2019-00055
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    January 1, 2013
    Report Date
    December 2, 2019
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2013. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE LOT HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: PERCUTANEOUS HEPATIC MICROWAVE ABLATION WITH HIGH-POWERED, GAS COOLED ANTENNAS: SHORT TERM RESULTS IN 87 PATIENTS AUTHORS: ZIEMLEWICZ T., HINSHAW J., LUBNER M., BRACE C., SAMPSON L., CENTER M. CITATION: JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY. 2013 JAN; CONFERENCE: SYMPOSIUM ON CLINICAL INTERVENTIONAL ONCOLOGY, CIO 2013. MIAMI BEACH, FL UNITED STATES. 24 (1) :145.E31-145.E32. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO REVIEW THE RESULTS IN THE FIRST 87 PATIENTS WITH MALIGNANT HEPATIC TUMORS TREATED WITH A NEW HIGH-POWER, GAS-COOLED MICROWAVE (MW) ABLATION DEVICE. BETWEEN DECEMBER 2010 AND SEPTEMBER 2012, 87 PATIENTS WERE ENROLLED IN THE STUDY. ALL PROCEDURES WERE PERFORMED WITH A HIGH-POWERED, GAS-COOLED MICROWAVE SYSTEM (CERTUS 140, NEUWAVE MEDICAL, MADISON, WI) UTILIZING 1-3 17-GAUGE ANTENNAS. REPORTED COMPLICATION INCLUDED RIGHT PLEURAL EFFUSION (N=2) REQUIRING THORACENTESIS FOR SYMPTOMATIC RELIEF; PORTAL VEIN CLOT (N=1) REQUIRING ANTI-COAGULATION. IN CONCLUSION, EARLY EXPERIENCE TREATING LIVER TUMORS USING A HIGH-POWERED, GAS-COOLED MICROWAVE ABLATION SYSTEM DEMONSTRATES EXCELLENT LOCAL CONTROL WITH MINIMAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298903 UNKNOWN_NEUWAVE SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention