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

Catalog Number	PR15XT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 10/5/2023.D4 batch #: unknown.Additional information was requested and the following was obtained: event description: after 7 minutes of 10 of treatment, an error message displayed.The antenna was blocked despite a channel change.The risks are manifold: partial removal of the liver nodule, recurrence of the partially treated nodule.No immediate patient consequence.During analysis of the returned probe, it was determined that the returned probe had a broken tip and the tip was not returned with the probe.Was the tip left inside of the patient? yes, the tip was left inside the patient.The ir didn¿t see it at first glance but we can see it on the scan below.Was the tip discarded? left in the patient.If the tip was left in the patient, are there any plans to retrieve the tip? no plan to retrieve the tip for now.The ir saw the patient one month post ablation.No sign of infection.The patient had an mri since then, no issue.He will see him again in october.Please describe the insertion approach.The ir is very experienced and has been using our system since 2017.Was any resistance encountered during insertion of the probes? no resistance encountered, no lateral force.Was a lateral force applied to the probe during insertion and/or during use? no.A manufacturing record evaluation is pending for the finished device lot number.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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 that during an ablation the probe stopped working.It stopped after 7 minutes of treatment.The radiologist restarted the ablation mode but the probe was not working.He plugged the probe back into another channel but it still didn't work.They used a second probe and the treatment went well afterwards.They were able to complete the procedure with no consequences for the patient.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/25/2023.Investigation summary: since this occurred in france, there is no call home data available.The probe returned and the tip was broken off and not included with the return.There was tissue char on the heat shrink and cannula.The tip was disassembled.The ceramic distal of the break was missing and pulled out from under the heat shrink.The inner conductor and brass cap were still attached.However there was evidence of thermal damage.The potential cause of the tip break is unknown due to the thermal damage seen.A search of nonconformities (ncs) was performed for lot ml22067853.There were no observed nonconformities for this lot.Manufacture date: 6/1/2022.Expiration date: 2/28/2026.

• Brand Name: NEUWAVE PR XT PROBE 15CM 15GA
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison WI 53704
• Manufacturer (Section G): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• Manufacturer Contact: kate karberg ; 3529 anderson st; madison, WI 53704 ; 3035526892
• MDR Report Key: 17878358
• Report Number: 3008769756-2023-00036
• Device Sequence Number: 20775925
• Product Code: NEY
• UDI-Device Identifier: 00853719006401
• UDI-Public: 853719006401
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: PR15XT
• Device Lot Number: ML22067853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown