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

Model Number	M001262050
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tines of the needle were difficult to retract.A 3.0/15/15 ph leveen standard needle electrode was used during a radiofrequency ablation procedure for a renal tumor.After deploying the device and successfully completing the ablation, the needles tines could not be retracted.Extra time was required to attempt retraction; eventually, the process succeeded and the device was removed.Once outside the patient, tissue was observed stuck between the tines, which had prevented proper retraction.Removal of the tissue allowed the tines to extend and retract as intended.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device history record (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.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a review of the rf probes device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.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 the tines of the needle were difficult to retract.A 3.0/15/15 ph leveen standard needle electrode was used during a radiofrequency ablation procedure for a renal tumor.After deploying the device and successfully completing the ablation, the needles tines could not be retracted.Extra time was required to attempt retraction; eventually, the process succeeded and the device was removed.Once outside the patient, tissue was observed stuck between the tines, which had prevented proper retraction.Removal of the tissue allowed the tines to extend and retract as intended.There were no patient complications as a result of this event.

• 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 ; 9529306396
• MDR Report Key: 24732175
• Report Number: 2124215-2026-17253
• Device Sequence Number: 10191706
• Product Code: GEI
• UDI-Device Identifier: 08714729300632
• UDI-Public: (01)08714729300632(17)280825(10)37300635
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/23/2026

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 Model Number: M001262050
• Device Catalogue Number: M001262050
• Device Lot Number: 0037300635
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 08/26/2025
• 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
• Patient Sex: Unknown