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

Catalog Number	PR15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 11/7/2024.B3: event year only reported: 2024.D4: batch #: unknown.Additional information was requested and the following was obtained: if the tip is still in the patient? yes the tip is still in the patient.There is no request that i am aware to have the tip sent back (as i believe it¿s still in the patient).This happened yesterday and i am not sure of status of patient.This is a cancer patient and if they were being monitored with mri than it will be an issue 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: how close were the probes when they were activated simultaneously? did the physician experience any unusual force while placing the probes? was a lateral force applied to the probe at any point during the procedure? did the probe require extra force during insertion? did the physician experience any resistance during insertion and/or use? are there any plans to retrieve the pieces that were left in the patient in the future? if yes, when? what is the patient¿s current status? attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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 when they were using the probes simultaneously while using the second probe in channel a the ablation system had shut down when the physician didn't do anything to make it do so.When they went to take the probe out of the patient, the tip of it had broken off.The tip is still in the patient.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/3/2024.Additional information was requested and the following was obtained: how close were the probes when they were activated simultaneously? about 1 cm.Did you experience any unusual force when placing the probe? no.Was a lateral force applied to the probe at any point during the procedure? no.Did the probe require extra force during insertion? no.Did you experience any resistance during insertion and/or use? no.Are there any plans to retrieve the pieces that were left if the patient or in the future? not for now.She was doing fine on follow up.What is the patient¿s current status? see above.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/23/2024.Investigation summary: call home revealed reflected power errors.According to the additional information provided, no excessive force was used and no resistance was felt during placement.The potential cause is unknown.The returned probe's tip was broken off and not included with the return.There was thermal damage at the breakage site.The potential cause is unknown due to the amount of thermal damage seen.A search of nonconformities (ncs) was performed for lot ml24059206.There were no observed nonconformities for this lot.Manufacture date: 05/01/2024.Expiration date: 01/31/2028.

• Brand Name: NEUWAVE PR PROBE 15CM 17GA
• 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 WI 53704
• Manufacturer Contact: kate karberg ; 3529 anderson st; madison, WI 53704 ; 3035526892
• MDR Report Key: 20630729
• Report Number: 3008769756-2024-00027
• Device Sequence Number: 7928886
• Product Code: NEY
• UDI-Device Identifier: 00853719006395
• UDI-Public: (01)00853719006395(17)280131(10)ML24059206
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2024

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 Catalogue Number: PR15
• Device Lot Number: ML24059206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 11/14/2024; 12/16/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/03/2024; 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown