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

Model Number	M001262280
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that roll-off was not achieved.A 3.0cm x 15cm leveen superslim needle electrode system was selected for use in a radiofrequency ablation procedure in the liver.After the needle electrode was inserted into the lesion and properly placed, ablation was performed at 60 watts for 5 minutes and 120 watts for 7 minutes, but the lesion showed no response under ultrasound imaging.The impedance indicator on the generator remained stable at around 130 and did not increase.The procedure was completed with a new needle electrode and the original generator.The tumor was successfully treated.There were no patient complications as a result of this event, and the patient was in stable condition following the procedure.
Event or Problem Description
It was reported that roll-off was not achieved.A 3.0cm x 15cm leveen superslim needle electrode system was selected for use in a radiofrequency ablation procedure in the liver.After the needle electrode was inserted into the lesion and properly placed, ablation was performed at 60 watts for 5 minutes and 120 watts for 7 minutes, but the lesion showed no response under ultrasound imaging.The impedance indicator on the generator remained stable at around 130 and did not increase.The procedure was completed with a new needle electrode and the original generator.The tumor was successfully treated.There were no patient complications as a result of this event, and the patient was in stable condition following the procedure.
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned for analysis.No visual damages were observed on the device.An electrical evaluation was performed by measuring the continuity, and the electrode was able to conduct current, indicating proper connectivity.A resistance test was performed, and the resistance between the electrode and corresponding tine measured within specification.The reported event was not confirmed.

• Brand Name: LEVEEN? SUPERSLIM?
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22579187
• Report Number: 2124215-2025-49482
• Device Sequence Number: 15762364
• Product Code: GEI
• UDI-Device Identifier: 08714729441717
• UDI-Public: (01)08714729441717(17)270418(10)33856223
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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 Model Number: M001262280
• Device Catalogue Number: M001262280
• Device Lot Number: 0033856223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 75 KG