MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NW ABLATION SYSTEM, US; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	NWC1US1N
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	05/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.Additional information was requested, and the following was obtained: how long post-op did event occur? can a timeline of event be provided?- unknown.How was the abscess treated?- unknown.Were cultures taken?- unknown.What is the radiologist¿s opinion of cause of abscess?- as per the radiologist, he felt he did too aggressive of an ablation regarding the time and number of probes.What is the current patient status?- unknown.
Event or Problem Description
It was reported that post-op to a kidney ablation procedure, the patient experienced a post-operative abscess.Additional treatment is currently unknown.

• Brand Name: NW ABLATION SYSTEM, US
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• MDR Report Key: 12216683
• Report Number: 3008769756-2021-00073
• Device Sequence Number: 3509234
• Product Code: NEY
• UDI-Device Identifier: 00853719006753
• UDI-Public: 00853719006753
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 06/24/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: NWC1US1N
• Device Catalogue Number: NWC1US1N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/23/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention