BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NW ABLATION SYSTEM, US

    MDR report key: 12067102 · Received June 25, 2021

    Report

    Report Number
    3008769756-2021-00040
    Event Type
    Injury
    Date Received
    June 25, 2021
    Date of Event
    January 1, 2020
    Report Date
    May 26, 2021
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    UDI-DI
    00853719006753
    PMA / PMN Number
    K160936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 6/25/2021. ONLY EVENT YEAR KNOWN: 2020; CAPTURED AS CITATION DATE. 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 NEUWAVE 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: COMPARISON OF RADIOFREQUENCY AND MICROWAVE ABLATION AND IDENTIFICATION OF RISK FACTORS FOR PRIMARY TREATMENT FAILURE AND LOCAL PROGRESSION. AUTHORS: JOSEPH L. MCDEVITTA, MICHAEL D. COLLARD, RYAN P. MURPHY, PATRICK D. SUTPHIN, ADAM C. YOPP, AMIT G. SINGAL, SANJEEVA P. KALVA CITATION: CLINICAL IMAGING 67 (2020) 146¿151. THE OBJECTIVES OF THIS RETROSPECTIVE REVIEW WERE TO COMPARE THE PRIMARY EFFICACY AND LOCAL PROGRESSION OF HEPATOCELLULAR CARCINOMA (HCC) TREATED WITH RADIOFREQUENCY ABLATION (RFA) AND MICROWAVE ABLATION (MWA) AND TO ASSESS THE IMPACT OF HCC SIZE, LOCATION, AND PROCEDURE RELATED FACTORS ON PRIMARY EFFICACY AND LOCAL TUMOR PROGRESSION. A TOTAL OF 110 UNIQUE HCC UNDERWENT THERMAL ABLATION PROCEDURES. 40 PATIENTS HAD MWA WITH 29 MALES AND 11 FEMALES. THERE MEAN AGE WAS 61.7 YEARS. THE IMPLANT USED WAS A 2.45 GHZ NEUWAVE CERTUS 140 MWA SYSTEM. (N=1) SEVERE ADVERSE EVENT WHICH WAS A CASE OF ARTERIAL INJURY THAT REQUIRED EMBOLIZATION. (N=1) MODERATE ADVERSE EVENT WHICH INCLUDED PNEUMOTHORAX REQUIRING PLACEMENT OF THORACOSTOMY TUBE. (N=1) MODERATE ADVERSE EVENT WHICH INCLUDED A THIRD DEGREE BURN FROM THE GROUNDING PAD. (N=3) MILD ADVERSE EVENTS WHICH INCLUDED PAIN REQUIRING OVERNIGHT ADMISSION. (N=3) MILD ADVERSE EVENTS WHICH INCLUDED HEMATOMAS THAT REQUIRED OVERNIGHT OBSERVATION. (N=1) MILD ADVERSE EVENTS WHICH INCLUDED CONSERVATIVELY-MANAGED BILOMA. (N=1) MILD ADVERSE EVENTS WHICH INCLUDED A SEVERE NAUSEA REQUIRING ADMISSION (N=9) PRIMARY FAILURES THAT UNDERWENT SUCCESSFUL REPEAT ABLATION, SO SECONDARY EFFICACY WAS ACHIEVED. (N=13) PRIMARY FAILURES NOT RE-TREATED WITH THERMAL ABLATION, 7 WERE TREATED WITH CHEMOEMBOLIZATION, 2 RECEIVED BEST SUPPORTIVE CARE DUE TO INTERVAL WORSENING OF LIVER DYSFUNCTION, 1 WAS TREATED WITH SORAFENIB FOR INTERVAL DEVELOPMENT OF METASTATIC DISEASE, AND 3 DID NOT RECEIVE FOLLOW-UP CARE IN THE HEALTH SYSTEM. (N=43) INTRAHEPATIC DISTANT RECURRENCE (IDR). THERE WAS NO SIGNIFICANT DIFFERENCE IN PRIMARY EFFICACY OR TIME TO LOCAL PROGRESSION BETWEEN PERCUTANEOUS RFA AND MWA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961905 NW ABLATION SYSTEM, US SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC. NWC1US1N 00853719006753

    Patients

    Seq Age Sex Outcome Treatment
    1