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	Abscess (1690); Hemorrhage/Blood Loss/Bleeding (1888); Pleural Effusion (2010); Peritonitis (2252); Obstruction/Occlusion (2422); Insufficient Information (4580)
Date of Event	12/10/2019
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 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: percutaneous thermal ablation of subcapsular hepatocellular carcinomas: influence of tumor-surface contact and protrusion on therapeutic efficacy and safety.Authors: akeanong worakitsitisatorn, david s.Lu, min woo lee, nazanin h.Asvadi, amin moshksar, alexander d.Yuen, justin mcwilliams, steven s.Raman.Citation: european radiology (2020) 30:1813¿1821; https://doi.Org/10.1007/s00330-019-06497-x.This study aimed to evaluate therapeutic efficacy and safety of percutaneous thermal ablation of subcapsular hepatocellular carcinomas (hccs) after categorizing them into nonsurface contact tumors and surface contact tumors with or without surface protrusion or exophytic appearance.During january 2011- june 2015, 290 patients who underwent radiofrequency ablation (rfa) or microwave ablation (mwa) as the first treatment with 474 hccs and 624 total ablation sessions were included in the study.There were 208 males and 82 females with a mean age of 64.5+-10 (range, 33-89) years.All procedures were performed with combined ultrasound and computed tomography (ct) guidance.Percutaneous ablations were performed under general anesthesia.There were 2 rfa systems used based on availability and operator¿s preference and 2 microwave ablation systems operating at 2.4 ghz were utilized: one is a competitor¿s device while the other was the certus device supporting up to three 17-gauge antennas (neuwave medical, ethicon).At the expected completion of ablation, a contrast ct was performed to better define the actual ablation zone.If ablation margins were unsatisfactory, additional energy delivery with or without applicator reposition was performed.After discharge, patients were followed up using contrast enhanced ct or mri at 1, 3, 6, 9, and 12 months and every 3¿6 months thereafter.The median follow-up of 15 months (range, 1¿87 months).Complications included local tumor progression in non-surface contact group (n=23.07%) and surface contact group (n=10%), pleural effusion (n=?), pneumothorax (n=?), hemothorax (n=?), intra-abdominal hemorrhage (n=?), liver abscess (n=?), liver decompensation (n=?), tumor seeding (n=?), cholecystitis (n=?), prolonged recovery (n=?), chf exacerbation (n=?), delirium (n=?), readmission with 1 month for small bowel obstruction (n=?), variceal bleeding (n=?), peritonitis (n=?).In conclusion, subcapsular hccs can be effectively treated with thermal ablation techniques.Degree of tumor-surface contact including moderate protrusion does not appear to limit feasibility or procedure effectiveness.

• 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: 12134543
• Report Number: 3008769756-2021-00062
• Device Sequence Number: 3411964
• Product Code: NEY
• UDI-Device Identifier: 00853719006753
• UDI-Public: 00853719006753
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 07/08/2021
• Patient Sequence Number: 1