MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE LK XT PROBE 20CM 15GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	LK20XT
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Abdominal Pain (1685); Pleural Effusion (2010); Insufficient Information (4580)
Date of Event	03/05/2021
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.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Additional information was requested, and the following was obtained: what was the location of tumor? segment 6 subcapsular.What was the ablation probe insertion path, i.E., intercostal or other? yes intercostal.How many probes were used? 2 probes.If the intercostal path was used, what respiration state (inspiratory vs expiratory) was the patient holding? any change of respiratory status during the insertion? expiratory state, no change during insertions.How was the pleural effusion identified? at 1 week scan, patient had also complains about dyspnea.Were there any issues experienced with device during procedure? not at all.What led the investigator to conclude the pleural effusion was possibly caused by device used in the procedure? disruption of collateral lymphatic in pleural cavity, diaphragm or intercostal area during thermal ablation may be responsible.A chylothorax is rare but may occur when the tumor is accessed through pleural space or if the tumors are located near the dome of the diaphragm.What is the current patient status? patient recovered well, he is on a mct diet and we will see him in out-patient clinic in 4 weeks.Then we will evaluate if we can stop the mct diet.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 clinical trial that the patient experienced a re-admission because of pleural effusion (chylothorax) and occlusion of arterial branch of segment 6/7.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/11/2021.Additional information received: the patient experienced post-ablation pain.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/12/2021.Additional information was requested and the following was obtained: patient has recovered/resolved from partial portal vein trombosis (segment 6/7 branch) and occlusion of arterial branch of segment 6/7.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/28/2022.Additional information was requested and the following was obtained: for the ae post-ablation pain, the relationship to study device value "unlikely" has been changed to "not related".
Additional Manufacturer Narrative
(b)(4).Date sent: 10/3/2023.Adverse event term: partial portal vein trombosis (segment 6/7 branch) severity value "mild" has been changed to "moderate".Adverse event term: occlusion of arterial branch of segment 6/7, segment 6/7 because of complete ablation of segment 6/7.Severity value "mild" has been changed to "moderate".

• Brand Name: NEUWAVE LK XT PROBE 20CM 15GA
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• Manufacturer (Section G): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• Manufacturer Contact: kara ditty-bovard ; 3529 anderson st; madison, WI 53704 ; 6107428552
• MDR Report Key: 11635228
• Report Number: 3008769756-2021-00008
• Device Sequence Number: 19707053
• Product Code: NEY
• UDI-Device Identifier: 00853719006388
• UDI-Public: 00853719006388
• 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: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/10/2021

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: LK20XT
• Device Catalogue Number: LK20XT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 04/12/2021; 10/11/2021; 06/24/2022; 10/02/2023
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/11/2021; 10/12/2021; 06/28/2022; 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male