MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE PR PROBE 20CM 17GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Catalog Number	PR20
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).The lot was not provided; therefore, a manufacturing record evaluation could not be performed.
Event or Problem Description
It was reported via literature entitled: microwave ablation of osteoid osteoma: safety and efficacy.Author(s): v.Gioioso, s.Reis, s.Brejt, s.Tulin-silver, d.Sperling, j.Susman, j.Weintraub, d.Mobley.Citation: jvir scientific e-posters; s243.The purpose of this study was to evaluate the safety and efficacy of ct-guided microwave ablation (mwa) of osteoid osteomas.From 2014 to 2017, 24 patients underwent mwa for osteod osteomas.A single pr microwave antenna ablation probe (neuwave medical) was placed in a coaxial manner into the nidus.Serial microwave ablations were performed, per protocol.Complication included probe fracturing in the lesion during positioning required surgical removal of the probe tip as well as the osteoid osteoma due to continued pain.There were no documented postprocedural complications of post biopsy or post-mwa hematoma or infection ct-guided microwave ablation is a well-tolerated, safe and effective treatment of osteoid osteoma.

• Brand Name: NEUWAVE PR PROBE 20CM 17GA
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• MDR Report Key: 8428998
• Report Number: 3008769756-2019-00024
• Device Sequence Number: 13502320
• Product Code: NEY
• UDI-Device Identifier: 00853719006418
• UDI-Public: 00853719006418
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

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 Catalogue Number: PR20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYSTEM - NWC1US1N
• Outcome Attributed to Adverse Event: Required Intervention