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

Catalog Number	PR20
Health Effect - Clinical Codes	Unspecified Infection (1930); Tissue Damage (2104); Hypoesthesia (2352)
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.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.Does the physician believe that the neuwave device caused or contributed to the patient complications mentioned in the article? if yes, please explain.
Event or Problem Description
It was reported via literature entitled: microwave ablation of osteoid osteoma: initial experience and efficacy.Author(s): elliot s.Rinzler, giridhar m.Shivaram, dennis w.Shaw, eric j.Monroe, kevin s.H.Koo.Citation: https://doi.Org/10.1007/s00247-018-4327-1.The purpose of this study was to retrospectively evaluate the technical feasibility and clinical efficacy of microwave ablation in the treatment of pediatric osteoid osteomas.Between january 1, 2015, and may 31, 2018, 24 pediatric patients, age range: 3-18; male: 15, female: 9 were evaluated and included in this study.During the procedure, the coring needle was then removed and the 17-gauge neuwave pr antenna (ethicon us, llc, somerville, nj) was advanced just beyond the distal edge of the lesion to cover the entire nidus within the antenna¿s ablation zone.A minimum of three ablation cycles were performed at a power setting of 30 watts, with a target temperature of 90 degrees celsius and a 30-s cooling period between cycles.Each ablation cycle lasted 30 s.Minor complications were seen in 4/24 (17%) patients.These included 3 patients with local skin numbness in the region of the access site (class a complication, two of which had spontaneously resolved at their 3- month follow-up), and one patient with a soft-tissue infection at the access site (class b complication, resolved with antibiotic treatment).There were no major complications.In conclusion, this study demonstrates that microwave ablation is a safe and efficacious technique for treating pediatric osteoid osteomas.The theoretical advantages of this technique require further study to determine non-inferiority to other established techniques and to evaluate long-term clinical response.Specific areas of future research could include determining the specific benefit of faster ablative techniques on procedural and anesthetic duration.

• 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: 8428659
• Report Number: 3008769756-2019-00020
• Device Sequence Number: 222442
• Product Code: NEY
• UDI-Device Identifier: 00853719006418
• UDI-Public: 00853719006418
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/21/2019

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: 02/21/2019
• 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 - NWA1US1N
• Outcome Attributed to Adverse Event: Required Intervention