BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUWAVE

    MDR report key: 12128653 · Received July 7, 2021

    Report

    Report Number
    3008769756-2021-00060
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    February 11, 2021
    Report Date
    June 8, 2021
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. 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. 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 DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: THERMAL ABLATION ALONE VS THERMAL ABLATION COMBINED WITH TRANSARTERIAL CHEMOEMBOLIZATION FOR PATIENTS WITH SMALL (<3 CM) HEPATOCELLULAR CARCINOMA AUTHORS: NATHAN X. CHAI , JULIUS CHAPIRO , ALEXANDRA PETUKHOVA , MORITZ GROSS , AHMET KUCUKKAYA ,RAJIV RAJU , TAL ZEEVI , MOHAMED ELBANAN , MINGDE LIN , JUAN CARLOS PEREZ-LOZADA ,TODD SCHLACHTER , MARIO STRAZZABOSCO , JEFFREY S. POLLAK , DAVID C. MADOFF CITATION: CLINICAL IMAGING 76 (2021) 123¿129 , HTTPS://DOI.ORG/10.1016/J.CLINIMAG.2021.01.043 THE AIM OF OUR STUDY WAS TO COMPARE THE TIME TO TUMOR PROGRESSION (TTP) AND OVERALL SURVIVAL (OS) FOR PATIENTS WHO RECEIVED TA ALONE OR TACE+TA FOR HCC TUMORS UNDER 3 CM. IN THIS HIPAA-COMPLIANT IRB-APPROVED RETROSPECTIVE STUDY, MEDICAL RECORDS FROM 85 PATIENTS FROM 2010 TO 2018 WERE COLLECTED WHO UNDERWENT EITHER TA ALONE (N = 64) OR EITHER DRUG-ELUTING BEADS (DEB)- TACE (N = 18) OR LIPIODOL-TACE (N = 3) TREATED CONSECUTIVELY WITH TA FOR LOCOREGIONAL THERAPY OF EARLY STAGE HCC. SIXTY-THREE MALE AND 22 FEMALE PATIENTS WERE INCLUDED IN THE ANALYSIS. AGES RANGED FROM 46 TO 82 YEARS, WITH MEAN AGE 62.4 ± 8.5 YEARS. TA MODALITIES INCLUDED MWA AND RFA PERFORMED UNDER ULTRASOUND AND/OR CT GUIDANCE. THESE PROCEDURES WERE PERFORMED BY MULTIPLE FELLOWSHIP-TRAINED INTERVENTIONAL RADIOLOGISTS WITH UP TO 21 YEARS OF EXPERIENCE. NEUWAVE (ETHICON, SOMERVILLE, NJ) PROBES WERE USED FOR MWA. FOR PATIENTS UNDERGOING ABLATION ALONE, PATIENTS RECEIVED EITHER RFA (N =35) OR MWA (N = 29). A SUBSET OF RFA PATIENTS (N = 13 OUT OF N = 35 TOTAL RFA PATIENTS) UNDERWENT LAPAROSCOPIC RFA. REPORTED COMPLICATIONS INCLUDED HEMORRHAGE (N=2), HEMOPERITONEUM (N=1), HEMATOMA (N=1), SUBSCAPULAR HEMATOMA (N=1). IN CONCLUSION FOR PATIENTS WITH HCC UNDER 3 CM, TA ALONE AND TACE+TA HAVE SIMILAR OUTCOMES IN TERMS OF TTP AND OS, SUGGESTING THAT TACE+TA MAY NOT BE NEEDED FOR THESE TUMORS UNLESS WARRANTED BY TUMOR LOCATION OR OTHER TECHNICAL CONSIDERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027144 UNKNOWN_NEUWAVE SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1