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

Model Number 36703

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/19/2022

Event Type  malfunction  

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 304017939
• Report Number: 2134265-2022-07756
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 08714729122487
• UDI-Public: 08714729122487
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K053128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 06/19/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 10/26/2022
• Supplement Dates FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 60 KG