MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LeVeen? Standard; electrosurgical, cutting & coagulation & accessories

Model Number	M001262160
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes	Abscess (1690); Fever (1858); Pain (1994); Pleural Effusion (2010); Sepsis (2067); Unspecified Tissue Injury (4559); High White Blood Cell Count (4594)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was injured, requiring further intervention.A leveen? standard probe was selected for use in an ablation procedure.During the procedure, roll-off was never achieved, which prolonged the procedure.The patient was discharged from the hospital on the same day.On (b)(6) 2026, 8 days after the ablation procedure, the patient presented to the hospital with pain, fever, and elevated white blood cell count.The patient was admitted to the hospital and computed tomography (ct) imaging revealed new right pleural fluid and possible liver abscess.The patient was diagnosed with sepsis around the diaphragm.The physician believed that the prolonged ablation resulted in damage to the diaphragm.The patient was put on antibiotics to treat the sepsis.On (b)(6) 2026, the patient was discharged from the hospital and stable at the time of reporting.The patient was scheduled for repeat imaging, but it had not yet been performed.

• Brand Name: LeVeen? Standard
• 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 ; +1(952)930-6396
• MDR Report Key: 25728058
• Report Number: 2124215-2026-36109
• Device Sequence Number: 21403469
• Product Code: GEI
• UDI-Device Identifier: 08714729454915
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2026
• Device Model Number: M001262160
• Device Catalogue Number: M001262160
• Device Lot Number: 0031905353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Supplement Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 07/06/2026
• Supplement Report FDA Received Date: 08/18/2026
• Date Device Manufactured: 06/27/2023
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 125 LB