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 08/26/2022

Event Type  malfunction  

Event Description

It was reported that insufficient roll-off occurred and the procedure was cancelled.The target lesion was located in the osteoid osteoma in the right leg tibia bone.The soloist needle was advanced through a 13 gauge 10cm biopsy needle.After positioning the soloist needle, the biopsy needle was pulled back 1.5 cm and ablation was started in the lesion.Lesion size was 7 mm.After the first ablation cycle of 15 min, no impedance was achieved.The impedance remained constant at 260 to 270.The 2nd cycle was started from 70% of the highest set power of 1st cycle, and continued for 5 min at the same power then start increasing power as 1watt/min, but impedance was not achieved.Impedance remained constant at 260 to 270.The same process was repeated 5 times and impedance was not achieved.The procedure was not completed due to this event.There were no patient complications and the patients status was stable.

• 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: 15459331
• MDR Text Key: 306110779
• Report Number: 2124215-2022-36199
• 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
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• 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: 0029303737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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: 16 YR
• Patient Sex: Male
• Patient Weight: 32 KG