MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE SR PROBE 25CM 13GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	NWSR25
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Urinary Retention (2119); Obstruction/Occlusion (2422); Cancer (3262)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported via journal article title: minimally invasive microwave ablation provides excellent long-term outcomes for otherwise inaccessible hepatocellular cancer authors: ariella m.Altman md, ms1, alexandria coughlan md1, dip m.Shukla bs1 , robben schat md2, benjamin spilseth md2, schelomo marmor mph, phd1, jane y.C.Hui md, ms1, todd m.Tuttle md, ms1, eric h.Jensen md1 citation cite:j surg oncol.2020;121:1218¿1224.Doi: 10.1002/jso.25924 the aim of this study is to evaluate the long-term oncologic outcomes of laparoscopic mwa for these otherwise inaccessible lesions.Of particular interest was evaluating the ability to target these previously inaccessible lesions successfully and to determine the risk of local recurrence at the site of ablation.A retrospective chart review was performed on all patients who underwent surgical mwa for hepatocellular carcinoma between 2009 and 2017.Thirty-three patients were identified.The median age of the cohort was 62 years old (interquartile range [iqr] 57-67).Twenty-five (76%) patients were male and 23 (70%) patients were white.Hepatitis c was the most common primary liver disease (22 patients, 67%) and 32 patients had underlying cirrhosis (97%).All patients included in the study were treated at a single tertiary referral center by one surgical oncologist.All procedures were performed in the operating room under general anesthesia.Laparoscopic access to the abdomen was obtained and a diagnostic laparoscopy was performed.After confirming the lack of presence of metastases, additional ports were placed to facilitate intraoperative ultrasound, the mwa probes and additional trocars as needed for retraction or dissection.All ablations were performed with a neuwave medical certus 140, 2.45 ghz ablation system (madison, wi) using neuwave certus pr xt 20 cm, or lk max xt 25 cm probes (neuwave; ethicon) depending on the size and location of the target tumor.Laparoscopic ultrasound was used to evaluate the liver and identify target lesions.Reported complications included grade i (n=6), gradeii (n=3), grade iii (n=1), ileus, worsening ascites, readmitted to the hospital within 30 days due to pain (n=2),urinary retention (n=1).After ablation pateints went on to recieve additional treatment for hcc (n=12), liver directed therapy (n=5), systemic therapy (n=5), transplant (n=4), systemic therapy followed by a liver transplant (n=1), both systemic and liver-directed treatments (n=1).With a median followup of 42.9 months patients treated with mwa had recurrent disease (n=13), recurrences at the site of a prioe ablation (n=2), developed intrahepatic recurrences (n=9), developed metastatic disease (n=2).In conclusion laparoscopic thermal ablation of hcc is safe and provides good oncologic outcomes for otherwise inaccessible tumors.

• Brand Name: NEUWAVE SR PROBE 25CM 13GA
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• MDR Report Key: 12060667
• Report Number: 3008769756-2021-00036
• Device Sequence Number: 19800847
• Product Code: NEY
• UDI-Device Identifier: 00853719006432
• UDI-Public: 00853719006432
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/25/2021

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: NWSR25
• Device Catalogue Number: NWSR25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/24/2021
• Patient Sequence Number: 1