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

Model Number	M001262260
Medical Device Problem Codes	Power Problem (3010); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital (b)(6).E1: initial reporter phone: (b)(6).Investigation results: device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported that insufficient roll-off occurred.A 2.0/17/15 leveen superslim was selected for an ablation procedure in the liver.After the needle lead was punctured to the designated position, the ablation was started.The console immediately stopped working, and the resistance value directly reached the maximum value and could not be ablated.There were no patient complications as a result of this event and the patient status was stable.

• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 25435619
• Report Number: 2124215-2026-30390
• Device Sequence Number: 10284125
• Product Code: GEI
• UDI-Device Identifier: 08714729441694
• UDI-Public: (01)08714729441694(17)260129(10)30945758
• 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
• Report Date (Section B): 06/08/2026

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 Expiration Date: 01/29/2026
• Device Model Number: M001262260
• Device Catalogue Number: M001262260
• Device Lot Number: 0030945758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 06/08/2026
• Date Device Manufactured: 01/30/2023
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 77 KG