BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUWAVE PR PROBE 15CM 17GA

    MDR report key: 12057833 · Received June 24, 2021

    Report

    Report Number
    3008769756-2021-00025
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    October 1, 2019
    Report Date
    May 25, 2021
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    UDI-DI
    00853719006395
    PMA / PMN Number
    K160936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: RENAL SUBCAPSULAR HEMORRHAGE ASSOCIATED WITH SUBCAPSULAR GAS DISSECTION DURING AND AFTER MICROWAVE ABLATION. SOMETHING TO WATCH FOR? AUTHORS: ALLEN KO, MS, JAMES B. VOGLER, IV, MD, HARLAN L. VINGAN, CITATION CITE:HTTPS://DOI.ORG/10.1016/J.JVIR.2019.07.034. THREE CASES OF RENAL SCH, ASSOCIATED WITH SUBCAPSULAR GAS EXPANSION AFTER MICROWAVE ABLATION, ARE DESCRIBED. INSTITUTIONAL REVIEW BOARD EXEMPTION WAS OBTAINED FOR THIS CASE SERIES. PATIENT 1 WAS A (B)(6) YEAR-OLD MALE WITH A 3.5-CM LEFT INTERPOLAR MASS, BIOPSY-PROVEN PAPILLARY RENAL CELL CARCINOMA, AND RENAL NEPHROMETRY SCORE OF 8X. RESECTION WAS CONTRAINDICATED DUE TO CARDIAC MORBIDITIES.PATIENT 2 WAS A (B)(6) YEAR-OLD MALE WITH A 3.2-CM LEFT UPPER POLE MASS, BIOPSY-PROVEN RENAL CELL CARCINOMA, AND RENAL NEPHROMETRY SCORE OF 7X. SURGERY WAS CONTRAINDICATED DUE TO CHRONIC CONGESTIVE HEART FAILURE AND LEFT VENTRICULAR ASSIST DEVICE. PATIENT 3 WAS A (B)(6) YEAR-OLD MALE WITH A 2.7-CM RIGHT LOWER POLE EXOPHYTIC ONCOCYTOMA TREATED DUE TO INTERVAL GROWTH AND A RENAL NEPHROMETRY SCORE OF 4P. SURGERY WAS CONTRAINDICATED DUE TO RECENT SUBMASSIVE PULMONARY EMBOLISM. PATIENTS 2 AND 3 HAD ANTICOAGULANT MEDICATIONS APPROPRIATELY HELD BEFORE THE PROCEDURE. ALL PATIENTS HAD NORMAL PROTHROMBIN TIMES, INTERNATIONAL NORMALIZED RATIOS, AND PLATELET COUNTS AT THE TIME OF INTERVENTION. BASED ON LESION SIZE, MICROWAVE ABLATION WITH 2 NEUWAVE PR-15 ANTENNAE (NEUWAVE MEDICAL, MADISON, WISCONSIN; ETHICON) WAS PERFORMED. IN THE AXIAL PLANE, BOTH ANTENNAE WERE PLACED INTRALESIONALLY, 1 CM APART, IN PARALLEL ORIENTATION TO EACH OTHER AND THE SHORT AXIS OF THE KIDNEY. MICROWAVE ABLATION WAS PERFORMED AT 65 W X 8 MINUTES WITH MAXIMUM ABLATION TEMPERATURES OF 135C. REPORTED COMPLICATIONS INCLUDED PATIENT 1- (B)(6) YEAR-OLD MALE NINE-MONTH FOLLOW-UP MULTIPHASE CT DEMONSTRATED A SMALL RESIDUAL SCH. PATIENT 2- (B)(6) YEAR-OLD MALE EXPERIENCED MILD FLANK PAIN AND WAS SUCCESSFULLY RESTARTED ON ANTICOAGULATION ON POSTOPERATIVE DAY 3. PATIENT 3 - (B)(6) YEAR-OLD MALE MODERATE ABDOMINAL DISCOMFORT AFTER MICROWAVE ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958965 NEUWAVE PR PROBE 15CM 17GA SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC. PR15 00853719006395

    Patients

    Seq Age Sex Outcome Treatment
    1