MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; Probe, Radiofrequency Lesion

Model Number	RCE-E401519-P
Medical Device Problem Codes	Nonstandard Device (1420); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a radiofrequency ablation (rfa) procedure, the injection electrode was inserted without difficulty, however it was difficult to reposition the device during the procedure.Upon device withdrawal, of the electrode and the cannula it was observed that the coating of the device was sheared.A new cannula and new electrode were utilized to successfully complete the procedure, and no issues were identified with the new devices.All pieces were removed from the patient's body, and the patient is doing well post operatively.

• Common Device Name: Probe, Radiofrequency Lesion
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): Boston Scientific Corporation; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50863920
• Report Number: 3006630150-2026-07019
• Device Sequence Number: 15808899
• Product Code: GXI
• UDI-Device Identifier: 00813250014341
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K082012
• 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
• Report Date (Section B): 09/23/2026

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: RCE-E401519-P
• Device Catalogue Number: RCE-E401519-P
• Device Lot Number: 36646987
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 05/30/2025
• 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