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	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that insufficient roll off occurred and the procedure was aborted.A soloist single needle electrode was selected for a radiofrequency ablation (rfa) treatment of an osteoid osteoma in the left femoral head.The lesion had a 6.0mm diameter nidus.The physician used a 11gauge x 10cm bone biopsy needle to gain access to the center of the nidus.After access to the center of the nidus was obtained, the soloist needle was placed through the biopsy needle.The biopsy needle was pulled back about 2cm to prevent any interference with the active part of the soloist needle.Four grounding pads were placed on the thighs of the patient.Ablation was started per the prescribed algorithm.It was noted that the first roll off didn't occur within the first 15 minutes of the procedure.The machine was stopped after the first 15 minutes completed.There was no change in impedance on the meter.After 60 seconds, the second round of ablation was started.There was no change in impedance for any wattage being changed.After 30 minutes into the second round of ablation, the physician requested to stop the procedure as there was no change in the impedance being shown on the monitor.The procedure was aborted.The patient was stable.There were no patient complications reported.
Additional Manufacturer Narrative
Device eval by manufacturer: the returned device consisted of one electrode needle.Visual inspection did not identify any damage or defect on the device.Functional testing was performed by electrical evaluation to measure the continuity.The electrode was able to conduct current indicating proper connectivity.Resistance test performed showed that it was 0.8ohms, which is within specification.The reported issue of insufficient roll-off was not confirmed through device analysis.
Event or Problem Description
It was reported that insufficient roll off occurred and the procedure was aborted.A soloist single needle electrode was selected for a radiofrequency ablation (rfa) treatment of an osteoid osteoma in the left femoral head.The lesion had a 6.0mm diameter nidus.The physician used a 11gauge x 10cm bone biopsy needle to gain access to the center of the nidus.After access to the center of the nidus was obtained, the soloist needle was placed through the biopsy needle.The biopsy needle was pulled back about 2cm to prevent any interference with the active part of the soloist needle.Four grounding pads were placed on the thighs of the patient.Ablation was started per the prescribed algorithm.It was noted that the first roll off didn't occur within the first 15 minutes of the procedure.The machine was stopped after the first 15 minutes completed.There was no change in impedance on the meter.After 60 seconds, the second round of ablation was started.There was no change in impedance for any wattage being changed.After 30 minutes into the second round of ablation, the physician requested to stop the procedure as there was no change in the impedance being shown on the monitor.The procedure was aborted.The patient was stable.There were no patient complications reported.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14117587
• Report Number: 2134265-2022-04348
• Device Sequence Number: 4399355
• 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): 06/17/2022

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: 12/07/2024
• Device Model Number: 36703
• Device Catalogue Number: 36703
• Device Lot Number: 0028546294
• 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: 03/23/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2021
• 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: 13 YR
• Patient Sex: Female