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

Model Number	M001262030
Medical Device Problem Codes	Retraction Problem (1536); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tines of the needle were difficult to retract.This 3.5/15/15 ph leveen standard needle electrode was selected for a radiofrequency ablation procedure to treat a liver tumor.After successfully deploying and performing the ablation using this device, resistance was felt when attempting to recapture the deployment tines.Due to the difficulty, it was removed with the deployment tines still extended.Once outside the body, it appeared that the tips of the deployment tines were covered with what seemed to be burned tissue, preventing their recapture.There was no patient injury.
Event or Problem Description
It was reported that the tines of the needle were difficult to retract.This 3.5/15/15 ph leveen standard needle electrode was selected for a radiofrequency ablation procedure to treat a liver tumor.After successfully deploying and performing the ablation using this device, resistance was felt when attempting to recapture the deployment tines.Due to the difficulty, it was removed with the deployment tines still extended.Once outside the body, it appeared that the tips of the deployment tines were covered with what seemed to be burned tissue, preventing their recapture.There was no patient injury.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this 3.5/15/15 ph leveen standard needle electrode was visually inspected, which revealed that the needles were bent.Functional inspection and testing was performed which found the needles could be extended and retracted normally.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21699401
• Report Number: 2124215-2025-12176
• Device Sequence Number: 7910034
• Product Code: GEI
• UDI-Device Identifier: 08714729300618
• UDI-Public: (01)08714729300618(17)261217(10)33082090
• 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): 05/08/2025

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: M001262030
• Device Catalogue Number: M001262030
• Device Lot Number: 0033082090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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: 80 YR
• Patient Sex: Male