BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUWAVE

    MDR report key: 20698752 · Received November 15, 2024

    Report

    Report Number
    3008769756-2024-00038
    Event Type
    Injury
    Date Received
    November 15, 2024
    Date of Event
    January 1, 2024
    Report Date
    November 15, 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: 11/15/2024. 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 ETHICON 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: PERCUTANEOUS MICROWAVE ABLATION FOR TREATMENT OF RETROPERITONEAL TUMORS AUTHORS: ANNIKA E. ROSSEBO, ANNIE M. ZLEVOR, BA, EMILY A. KNOTT, BS, LU MAO, PHD, ALLISON B. COUILLARD, MD, TIMOTHY J. ZIEMLEWICZ, MD, J. LOUIS HINSHAW, MD, E. JASON ABEL, MD, MEGHAN G. LUBNER, MD, ERICA M. KNAVEL KOEPSEL, MD, SHANE A. WELLS, MD, LINDSAY M. STRATCHKO, DO, PAUL F. LAESEKE, MD, PHD, FRED T. LEE, JR, MD. CITATION: RADIOLOGY: IMAGING CANCER 2024; 6(2): E230080. HTTPS://DOI.ORG/10.1148/RYCAN.230080. THE PRIMARY PURPOSE OF THIS RETROSPECTIVE, SINGLE-CENTER STUDY WAS TO DETERMINE IF MWA OF RETROPERITONEAL TUMORS RESULTS IN A LOW INCIDENCE OF LOCAL TUMOR PROGRESSION (LTP) WITH FEW SEVERE COMPLICATIONS. A TOTAL OF 29 TUMORS (27 METASTASES AND TWO PRIMARY TUMOR RECURRENCES IN THE RETROPERITONEUM) TREATED OVER 22 PROCEDURES IN 19 PATIENTS (MEDIAN AGE, 65 YEARS [RANGE = 46¿78 YEARS]; 13 [68.4%] MEN AND SIX [31.6%] WOMEN) WITH RETROPERITONEAL TUMORS TREATED WITH MWA BETWEEN 2011 AND 2021 WERE INCLUDED IN THE STUDY. A MULTIPROBE, GAS-COOLED, IN-PHASE, 2.45-GHZ MWA SYSTEM WAS USED FOR ALL PROCEDURES (NEUWAVE MICROWAVE ABLATION SYSTEM; ETHICON). THE MEDIAN FOLLOW-UP WAS 18 MONTHS (RANGE = 0.5¿113 MONTHS). REPORTED COMPLICATIONS INCLUDE URINARY RETENTION REQUIRING FOLEY CATHETER PLACEMENT (N=2) AND CHRONIC QUADRICEPS WEAKNESS DUE TO THE FEMORAL NERVE BEING IMMEDIATELY ADJACENT TO THE TARGET TUMOR (N=1; 46-YEAR-OLD MALE). IN CONCLUSION, TREATMENT OF RETROPERITONEAL TUMORS WITH MWA COMBINED WITH HYDRODISSECTION PROVIDED HIGH RATES OF LOCAL CONTROL, PROLONGED SYSTEMIC THERAPY-FREE INTERVALS, AND FEW SERIOUS COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334744 UNKNOWN_NEUWAVE SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention