MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE LK PROBE 15CM 17GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Catalog Number	LK15
Health Effect - Clinical Codes	Nausea (1970); Pain (1994); Pleural Effusion (2010); No Consequences Or Impact To Patient (2199); Injury (2348); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).The lot was not provided; therefore, a manufacturing record evaluation could not be performed.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 physician believe that the neuwave device caused or contributed to any of the patient complications mentioned in the article? if yes, please explain.
Event or Problem Description
It was reported via literature entitled: "microwave ablation of malignant hepatic tumours: intraperitoneal fluid instillation prevents collateral damage and allows more aggressive case selection." author(s): douglas kitchin, meghan lubner, tim ziemlewicz, j.Louis hinshaw, marci alexander, christopher l.Brace & fred lee.Citation: int j hyperthermia, 2014; 30 (5): 299¿305; doi: 10.3109/02656736.2014.936050.This retrospective study aimed to review our experience utilizing protective fluid instillation techniques during percutaneous microwave (mw) ablation of liver tumours to determine if fluid instillation prevents non-target injuries and allows a more aggressive case selection.Between 2008 and 2012, 151 hepatic tumours in 87 patients (n=70 men and n=17 women) underwent percutaneous mw ablation procedures for malignant hepatic lesions.One to three high-powered gas-cooled antennas (lk or pr antennas, certus 140, neuwave medical, madison, wi) were utilized in each procedure.Twenty nine of 151 utilized fluid administration in which 122 were considered as control group.Complications included postprocedural portal venous thrombus (n=1), thermal injury of the diaphragm resulting in pleural effusion requiring two thoracentesis (n=1), body wall pain (n=6; for both groups), and prolonged nausea (n=1).This study demonstrates that intraperitoneal fluid administration is a safe and effective method of protecting non-target structures during percutaneous hepatic mw ablation.The use of hydrodisplacement allowed microwave ablation to be performed in cases that otherwise would be unsafe due to the risk of damage to vulnerable structures such as bowel.While mw ablation cases utilising fluid instillation allows more aggressive case selection, these were associated with higher rates of local tumour progression.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent: 3/28/2019.Corrected data: type of reportable event: not reportable.Patient codes.Additional information was requested and the following was obtained: does the physician believe that the neuwave device caused or contributed to any of the patient complications mentioned in the article? if yes, please explain.Response: none of the complications described were specific to the neuwave products.Yes, ablation results in complications, but nothing that i believe was caused by the design of the product.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• Brand Name: NEUWAVE LK PROBE 15CM 17GA
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• MDR Report Key: 8444509
• Report Number: 3008769756-2019-00029
• Device Sequence Number: 10851246
• Product Code: NEY
• UDI-Device Identifier: 00853719006357
• UDI-Public: 00853719006357
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K160936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

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 Catalogue Number: LK15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention