BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUWAVE

    MDR report key: 20673866 · Received November 13, 2024

    Report

    Report Number
    3008769756-2024-00031
    Event Type
    Injury
    Date Received
    November 13, 2024
    Date of Event
    April 10, 2024
    Report Date
    November 13, 2024
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 11/13/2024. B3: PUBLICATION YEAR OF 2024. D4: BATCH # UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT THE NEUWAVE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE: CLINICAL SAFETY AND EFFICACY OF MICROWAVE ABLATION FOR SMALL RENAL MASSES AUTHOR(S): ASHLEY FORET, CHRISTOPHER B. HAAGA JR., SHIVANI JAIN, CHELSEA O. BAUMGARTNER, MEGAN ESCOTT, BENJAMIN R. HENDERSON, SEAN T. O¿BRIEN, SCOTT E. DELACROIX JR., JESSIE R.R. GILLS, MARY E. WESTERMAN CITATION: INT BRAZ J UROL. 2024; VOL. 50 (3): 277-286, MAY - JUNE, 2024, DOI: 10.1590/S1677-5538.IBJU.2024.0017. THIS STUDY AIMS TO CLARIFY THE UTILITY OF CT-GUIDED MICROWAVE ABLATION BY EXAMINING PATIENT OUTCOMES SUCH AS RECURRENCE, TREATMENT SUCCESS, CHANGES IN RENAL FUNCTION, AND COMPLICATIONS. BETWEEN 2015 AND 2022, 104 PATIENTS WITH SMALL RENAL MASSES (108) WHO UNDERWENT SAME DAY RENAL MASS BIOPSY AND CT-GUIDED MICROWAVE ABLATION WERE INCLUDED IN THE STUDY. THE MEDIAN AGE FOR PATIENTS WAS 72.2 YEARS AND 60 WERE MALE. THE MEDIAN BMI WAS 31 KG/M2. FOR THE ABLATION PROCEDURE, THE NEUWAVE LK OR PR PROBE (ETHICON, RARITON, NEW JERSEY) WAS USED IN EITHER 14, 15, 17, OR 19 GAUGE. ABLATION WAS PERFORMED UNTIL ADEQUATE ABLATIVE ZONES WERE ACHIEVED. POST-PROCEDURAL AND DELAYED IMAGING WERE OBTAINED WHEN INDICATED. REPORTED COMPLICATIONS INCLUDED URINARY RETENTION (N=1), RENAL HEMATOMA (N=2), CONGESTIVE HEART FAILURE EXACERBATION (N=1), INTRAOPERATIVE PLEURAL EFFUSION (N=1), DUODENAL PERFORATION (N=1), PNEUMOTHORAX (N=1), AND COLLECTING SYSTEM EXTRAVASATION (N=1). IN CONCLUSION, AS THE MEDICAL FIELD CONTINUES TO EVOLVE TOWARDS LESS INVASIVE INTERVENTIONS, MICROWAVE ABLATION OFFERS A VALUABLE TOOL IN THE MANAGEMENT OF RENAL MASSES. WITH LOW MAJOR COMPLICATION AND RECURRENCE RATES, OUR FINDINGS SUPPORT THE UTILITY OF CT-GUIDED MICROWAVE ABLATION AS A TOOL FOR TREATMENT OF SMALL RENAL MASSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069265 UNKNOWN_NEUWAVE SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention