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

Model Number	PR15
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Ischemia (1942); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.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: can more information be provided regarding the infarction? does the investigator believe there any device deficiency/malfunction that may have caused or contributed to the infarction? not enough data provided to perform a call home investigation.No device will be returned to neuwave for further investigation.The root cause is unknown.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that during clinical trial (b)(6), during a microwave ablation of soft tissue liver lesions, the patient experienced infarction.There is no relationship to the study procedure but there is a probable relationship to the study device.No treatment was provided.The patient has recovered/incident was resolved.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/14/2022.Additional information was requested and the following was obtained: on the ablation procedure report (b)(6) 2021 an infarction was noted in the artery supplying segment 8.The infarction occurred due to probe placement within an artery.There were no clinical sequelae.This was not device related.The device performed as it should have.It was placed near a segmental artery by choice of the operator to treat the tumor.The segmental infarct was a necessity and anticipated potential complication.I view this as event as being within the range of minor complications associated thermal ablation, regardless of device.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 PR PROBE 15CM 17GA
• 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: orla o'mahony ; 3529 anderson st; madison, WI 53704 ; 6107428552
• MDR Report Key: 14073687
• Report Number: 3008769756-2022-00017
• Device Sequence Number: 19491015
• Product Code: NEY
• UDI-Device Identifier: 00853719006395
• UDI-Public: 00853719006395
• 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
• Report Date (Section B): 04/11/2022

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 Model Number: PR15
• Device Catalogue Number: PR15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 04/14/2022
• 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 Sex: Unknown