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 Code	Insufficient Information (4580)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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?.
Event or Problem Description
It was reported via journal article title: comparing outcomes for patients with clinical t1b renal cell carcinoma treated with either percutaneous microwave ablation or surgery daniel d.Shapiro, shane a.Wells, sara l.Best, sean p.Hedican, timothy j.Ziemlewicz, meghan g.Lubner, james louis hinshaw, fred t.Lee jr, david f.Jarrard, kyle a.Richards, tracy m.Downs, glenn o.Allen, stephen y.Nakada, and edwin jason abel citation: urology 135, 2020 https://doi.Org/10.1016/j.Urology.2019.09.024 this study aims to compare perioperative and oncologic outcomes for patients with ct1b renal cell carcinoma (rcc) following treatment with percutaneous microwave ablation (mw), radical nephrectomy (rn), or partial nephrectomy (pn).Between january 2000 and june 2018 at the university of wisconsin,325 patients with rcc pathologic diagnosis and radiographic 4-7 cm tumor diameter were identified and treated with either percutaneous mw, pn, or rn.There were 40 patients in mw cohort (30 males, 10 females) age 69 (65-77 years).All ablations were performed under general anesthesia and immediate postablation computed tomography (ct) was performed to ensure adequate tumor destruction.Ablations were performed with a 2.45 ghz, gas-cooled mw system using 17-gauge antennas (certus 140, neuwave medical).After mw treatment, surveillance imaging was obtained every 6 months for 2 years and annually thereafter consisting of contrast enhanced abdominal ct or magnetic resonance imaging and chest imaging.Median follow-up interval for mw, pn, rn was 33.9 months (iqr 21.7-61.2), 35.1 months (iqr 9.5-89), and 49.5 months (iqr 16.1-87.7), respectively.Reported complication included: residual tumor identified on initial postoperative imaging requiring a second ablation due to incomplete initial treatment(n-2).High-grade complications identified within 90 days postoperatively (n=4).Local recurrence rate 5.0% (n=2),patients underwent repeat ablation without subsequent recurrence on follow-up imaging.Post-treatment estimated glomerular filtration rate decreased by median 4.5% (n=?).It was concluded, that percutaneous mw is a feasible alternative treatment for appropriately selected patients with ct1b rcc tumors.

• 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: 12128095
• Report Number: 3008769756-2021-00059
• Device Sequence Number: 3529827
• 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): 06/08/2021

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: 06/08/2021
• Initial Report FDA Received Date: 07/07/2021
• Patient Sequence Number: 1