MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NW ABLATION SYSTEM, US; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	NWC1US1N
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hematoma (1884); Nausea (1970); Pain (1994); Pneumothorax (2012); Full thickness (Third Degree) Burn (2696); Embolism/Embolus (4438); Insufficient Information (4580)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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?.
Event or Problem Description
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.

• Brand Name: NW ABLATION SYSTEM, US
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• MDR Report Key: 12067102
• Report Number: 3008769756-2021-00040
• Device Sequence Number: 17035215
• Product Code: NEY
• UDI-Device Identifier: 00853719006753
• UDI-Public: 00853719006753
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NWC1US1N
• Device Catalogue Number: NWC1US1N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/25/2021
• Patient Sequence Number: 1