MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLOIST?; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	M001262500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter address 2: (b)(6).
Event or Problem Description
It was reported that the patient experienced pain as a result of the device or procedure and required medication.Soloist radiofrequency ablation (rfa) probes were selected for use to treat a pediatric patient with an osteoid osteoma.Pre-procedure ct (computed tomography) (0.6 mm) and contrast mri (magnetic resonance imaging) had clearly demonstrated a classical nidus.Intra-procedural ct images unequivocally show that the rfa probe tip was placed precisely within the nidus, with correct trajectory and depth.Energy delivery was performed strictly as per manufacturer-recommended parameters.However, recent follow-up mri demonstrates persistent, enhancing nidus with continued clinical symptoms, conclusively establishing that the lesion had not been ablated.The patient experienced worsening and prolonged pain and discomfort as a result of the device or procedure, and required medication to be administered.The patient was prescribed naproxen for 5 days following the procedure.

• Brand Name: SOLOIST?
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24308658
• Report Number: 2124215-2026-07526
• Device Sequence Number: 21252326
• Product Code: GEI
• UDI-Device Identifier: 08714729122487
• UDI-Public: (01)08714729122487(17)271204(10)35502571
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K053128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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: M001262500
• Device Catalogue Number: M001262500
• Device Lot Number: 0035502571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/10/2026
• Date Device Manufactured: 12/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 3 YR
• Patient Sex: Female