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

Model Number	M001262230
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Good faith effort attempts were made to retrieve additional details regarding the reported event and the device status, but further information was unable to be obtained.
Event or Problem Description
It was reported that the ablation area was larger than expected.A leveen coaccess and a rf3000 radiofrequency generator were selected for a pulmonary radiofrequency procedure.During the procedure, the leveen coaccess needle was correctly placed in the target area.The treatment time parameters were 1 minute 28 seconds at 10w, then 4 minutes at 15w, and finally 10 seconds at 10w.During the first treatment session, the parameters fluctuated more rapidly than usual (increasing up to 20w).There was no drop in power delivery during the three ablation attempts.The desired ablation area was 3cm.The thermoablation area was abnormally large, approximately 5 cm, for a treatment delivered at about 10 to 15 watts.The ablation area was larger than expected.

• Brand Name: LeVeen? CoAccess?
• 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: 25594311
• Report Number: 2124215-2026-33301
• Device Sequence Number: 5481823
• Product Code: GEI
• UDI-Device Identifier: 08714729295617
• UDI-Public: (01)08714729295617(17)281113(10)37963773
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026

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 Model Number: M001262230
• Device Catalogue Number: M001262230
• Device Lot Number: 0037963773
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/22/2026
• 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: 05/26/2026
• Supplement Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 06/23/2026
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown