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

Model Number	PR20XT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Abdominal Pain (1685); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: was patient re-admitted after being discharged, without any complaints, on november 26th? correct, patient was discharged in the morning on 26-nov and later that day, in the evening re-admitted because of pain complaints.Then the next day discharged again after pain was under control with pain medication.To know what the reasons are that this event could possibly be related to the study device and is this further investigated? has there been a device issue? no, but the definition of this is not entirely clear to me (i can't see it in ecrf either).There was no failure of the device, but complication is of course very possible related to the application of the ablation (in accordance with all regulations and normal procedures).Not with the device itself.Can you provide a summary of this event for the medical team for review? nov 25 percutaneous mwa at 2x hcc segment 8 and segment 2.First lesion (seg.8) two ablations 10 min 65w and additional 5 min 65w with 2x pr20xt.Second lesion (seg.2) in close relation to the stomach for which co2 was introduced prior to initiation of ablation to deviate the stomach.With good result, ablation starts, 2 needles 10 min 65w and additional 1 needle 10 min 65w.No complications on post-ablation ct.Pt.Recovers well in the ward and can go home the next day in the morning.In the course of that evening she has pain in the upper abdomen and returns to the emergency room.After analysis, a ct abdomen is made which shows no indications of bleeding or perforation (after the procedure some air is still present in the abdominal cavity due to co2 dissection).The pain may be related to ablation close to diaphragm (lesion seg.8) or related to co2 in the abdominal cavity.Mrs.Is admitted for observation.After starting oxycodone, pain is acceptable and mrs.Back home the next morning.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 an ablation procedure during a clinical trial the patient experienced abdominal pain.It required additional hospitalization, drug therapy, diagnostic imaging, and observation.There is a possible relationship to the study device.The patient has recovered.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/21/2021 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 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: 13042452
• Report Number: 3008769756-2021-00100
• Device Sequence Number: 14804876
• Product Code: NEY
• UDI-Device Identifier: 00853719006425
• UDI-Public: 00853719006425
• Combination Product (Y/N): N
• 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,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PR20XT
• Device Catalogue Number: PR20XT
• 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: 11/29/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 12/21/2021
• 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: 74 YR
• Patient Sex: Female