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

Model Number	36721
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the needle caused a burn.A radio frequency ablation procedure was being performed on a tumor for a patient with liver cancer.The leveen standard was being used for this procedure.When the needle was in position and the ablation was occurring the needle was hot and smoking which resulted in the patient becoming burned.The procedure was completed with this device.After the procedure, the patient was considered stable.
Additional Manufacturer Narrative
Device evaluated by mfr: one rf probe was returned for analysis.No visual damages defects were observed on the electrode.The electrode connector and cable connector did not have any visual defect.A functional evaluation extended and retracted the tines without resistance.The tines were evenly spaced and undamaged.An electrical evaluation was performed by measuring the continuity, the electrode was able to conduct current indicating proper connectivity.The resistance test for the electrode and the cable were within specification.
Event or Problem Description
It was reported that the needle caused a burn.A radio frequency ablation procedure was being performed on a tumor for a patient with liver cancer.The leveen standard was being used for this procedure.When the needle was in position and the ablation was occurring the needle was hot and smoking which resulted in the patient becoming burned.The procedure was completed with this device.After the procedure, the patient was considered stable.

• Brand Name: LEVEEN STANDARD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10697370
• Report Number: 2134265-2020-14256
• Device Sequence Number: 19703600
• Product Code: GEI
• UDI-Device Identifier: 08714729295594
• UDI-Public: 08714729295594
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K140500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2022
• Device Model Number: 36721
• Device Catalogue Number: 36721
• Device Lot Number: 0023652390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR