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

Model Number	M001262220
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was difficulty deploying the electrode.A 3.0cm x 15cm leveen coaccess needle electrode system was selected for use in a radio frequency ablation procedure in the liver.Outside the patient, when deploying the electrode, unusual resistance was felt.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned for analysis.The cable, rf probes, and the metal cannula were returned for analysis.No damage was observed.Functional testing was performed, and the needles extended normally.The reported allegation was not confirmed.
Event or Problem Description
It was reported that there was difficulty deploying the electrode.A 3.0cm x 15cm leveen coaccess needle electrode system was selected for use in a radio frequency ablation procedure in the liver.Outside the patient, when deploying the electrode, unusual resistance was felt.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22522451
• Report Number: 2124215-2025-47585
• Device Sequence Number: 20990852
• Product Code: GEI
• UDI-Device Identifier: 08714729454922
• UDI-Public: (01)08714729454922(17)261205(10)32999787
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140495
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: M001262220
• Device Catalogue Number: M001262220
• Device Lot Number: 0032999787
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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 Sex: Unknown