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

Catalog Number	PR20XT
Medical Device Problem Codes	Connection Problem (2900); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an ablation a probe was connected to channel 2, did the test successfully in water.The probe was in the patient.Before pressing the tissue loc button, the test button was no longer ¿checked¿.The test was redone with the probe in the patient but then couldn't redo the test.The channel was switched and reconnected the same needle to channel 1.Impossible to redo the test.The system was turned off completely.Turned it on, tried to do the test with the probe in the patient : error message appeared : change channel, or change probe and send it to quality dept.The system didn't recognize that there was a procedure in progress: got a "procedure not open" message.The radiologists wanted to use 3 probes.They didn¿t have any extra probes available.They decided to postpone the case in may.Possible incidence of cancer cell seeding by moving the probe and not being able to ablate and do the track ablation.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/29/2024.D4 batch #: unknown.Additional information was requested and the following was obtained: what is the patient¿s current status? the patient was not treasted at all with our device.Did any patient harm occurred due to the malfunction of the device? possible incidence of cancer cell seeding by moving the probe and not being able to ablate and do the track ablation.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 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/20/2024.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/10/2024.Investigation summary.Since this occurred in france, there is no call home data available.The returned probe as disassembled and a pinch in the peek tube (cooling line) was found within the probe head.This caused the cooling errors seen.The potential cause of the pinch is manufacturing since this probe had no uses before issuing errors.A search of nonconformities (ncs) was performed for lot ml23088429.There were no observed nonconformities for this lot.Manufacture date: 8/1/2023.Expiration date: 4/30/2027.

• Brand Name: NEUWAVE PR XT PROBE 20CM 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 53704 ; 3035526892
• MDR Report Key: 19200687
• Report Number: 3008769756-2024-00008
• Device Sequence Number: 8021750
• Product Code: NEY
• UDI-Device Identifier: 00853719006425
• UDI-Public: 853719006425
• 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,Followup
• Report Date (Section B): 04/29/2024

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: PR20XT
• Device Lot Number: ML23088429
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 06/06/2024; 07/08/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 06/21/2024; 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown