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	06/19/2022
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 the radiofrequency ablation of an osteoid osteoma.A 13 gauge x 10cm bone biopsy needle was placed on the nidus and the soloist needle was passed through it.Ablation was started and ran for 15 minutes.After 15 minutes, impedance was not achieved and ablation was restarted.Impedance was unable to be achieved during the second attempt.The soloist needle was repositioned but impedance could not be achieved.The needle was removed and the procedure was completed with another device.There were no patient complications reported.
Event or Problem Description
It was reported that insufficient roll off occurred.A soloist single needle electrode was selected for the radiofrequency ablation of an osteoid osteoma.A 13 gauge x 10cm bone biopsy needle was placed on the nidus and the soloist needle was passed through it.Ablation was started and ran for 15 minutes.After 15 minutes, impedance was not achieved and ablation was restarted.Impedance was unable to be achieved during the second attempt.The soloist needle was repositioned but impedance could not be achieved.The needle was removed and the procedure was completed with another device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: one electrode needle was returned for analysis and its respective connection cable.No visual damages defects were observed on the electrode needle.An electrical evaluation was performed by measuring the continuity, the electrode was able to conduct current indicating proper connectivity.

• Brand Name: SOLOIST
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14991436
• Report Number: 2134265-2022-07756
• Device Sequence Number: 1597090
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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 Expiration Date: 01/25/2025
• Device Model Number: 36703
• Device Catalogue Number: 36703
• Device Lot Number: 0028768923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2022
• 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
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 60 KG