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

Model Number	36703
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that insufficient roll off occurred.A soloist single needle electrode was selected for use in an osteoid osteoma radiofrequency ablation procedure.During the procedure, the impedance was not rising.After multiple attempts, the tumor could not be ablated, and the case was abandoned.
Event or Problem Description
It was reported that insufficient roll off occurred.A soloist single needle electrode was selected for use in an osteoid osteoma radiofrequency ablation procedure.During the procedure, the impedance was not rising.After multiple attempts, the tumor could not be ablated, and the case was abandoned.
Additional Manufacturer Narrative
Device eval by manufacturer: the device and the cable were returned for analysis.During its analysis, the electrical inspection passed because the electrode was able to conduct current, indicating proper connectivity, which does not confirm the reported event.Additionally, the visual inspection passed since no damages were observed.

• 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: 20547027
• Report Number: 2124215-2024-67421
• Device Sequence Number: 20830237
• Product Code: GEI
• UDI-Device Identifier: 08714729122487
• UDI-Public: 08714729122487
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 36703
• Device Catalogue Number: 36703
• Device Lot Number: 0033058248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown