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

Model Number	M001262260
Medical Device Problem Codes	Failure to Unfold or Unwrap (1669); Adverse Event Without Identified Device or Use Problem (2993); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle electrode failed to deploy properly.A 2.0cm x 15cm leveen? superslim? needle electrode was selected for use in a radiofrequency ablation procedure in the left liver.During the procedure, the needle electrode failed to deploy properly.The procedure was completed with another of the same device.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 the needle electrode failed to deploy properly.A 2.0cm x 15cm leveen? superslim? needle electrode was selected for use in a radiofrequency ablation procedure in the left liver.During the procedure, the needle electrode failed to deploy properly.The procedure was completed with another of the same device.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.Visual examination revealed that the shaft was kinked.Functional testing was performed, and the needles were extended and retracted normally.The reported event could not be 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: 23419246
• Report Number: 2124215-2025-77929
• Device Sequence Number: 10431893
• Product Code: GEI
• UDI-Device Identifier: 08714729441694
• UDI-Public: (01)08714729441694(17)280331(10)36200757
• 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): 12/02/2025

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: M001262260
• Device Catalogue Number: M001262260
• Device Lot Number: 0036200757
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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 Sex: Male