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

Model Number 36703

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Burn(s) (1757); Necrosis (1971)

Event Date 06/25/2021

Event Type  Injury  

Manufacturer Narrative

Event date was not reported and approximated as (b)(6) 2021.

Event Description

It was reported the patient experienced a puncture site burn requiring additional intervention and extended hospitalization.A rf3000 gen 200w 230v along with a soloist needle were used in a radiofrequency ablation procedure treating an osteoid osteoma.During the procedure roll off took a very long time and caused a skin burn at the needle insertion site.The patient returned to the hospital a few days later, with skin necrosis, and was hospitalized.A secondary procedure was performed to complete a skin graft.Progressive improvement at 3 months, was noted.

Event Description

It was reported the patient experienced a puncture site burn requiring additional intervention and extended hospitalization.A rf3000 gen 200w 230v along with a soloist needle were used in a radiofrequency ablation procedure treating an osteoid osteoma.During the procedure roll off took a very long time and caused a skin burn at the needle insertion site.The patient returned to the hospital a few days later, with skin necrosis, and was hospitalized.A secondary procedure was performed to complete a skin graft.Progressive improvement at 3 months, was noted.It was further reported the osteoid osteoma was located in the tibia.The patient was hospitalized for a few days after the radiofrequency procedure, then went home for 4 weeks to heal the wound with directed healing.The patient returned for outpatient surgery on (b)(6) 2021 to have a skin flap graft to close the wound permanently.The patient is better and the wound is healed.It was noted the rf3000 console was checked and no anomalies were detected.

Manufacturer Narrative

Additional information: b3: event date was originally approximated as (b)(6) 2021, has been updated to (b)(6) 2021.B5: describe event or problem - updated.D4: lot number, expiration date, unique identifier (udi) # - updated.H4: device manufacture date - updated.

• 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
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12530336
• MDR Text Key: 273329941
• Report Number: 2134265-2021-12075
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K053128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2022
• Device Model Number: 36703
• Device Catalogue Number: 36703
• Device Lot Number: 0024484067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 14 YR
• Patient Sex: Male