MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; PROBE, RADIOFREQUENCY LESION

Model Number	TCD-10-3M
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a radio frequency ablation procedure, the patient was administered general anesthesia; however, the electrode did not heat to the correct temperature and the procedure was unable to be performed.There were no patient complications due to the event.
Additional Manufacturer Narrative
The returned electrode was analyzed, passed all tests performed, and exhibited normal device characteristics.Therefore, the reported event of the electrode not heating to the correct temperature could not be confirmed.
Event or Problem Description
It was reported that during a radio frequency ablation procedure, the patient was administered general anesthesia; however, the electrode did not heat to the correct temperature and the procedure was unable to be performed.There were no patient complications due to the event.

• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 18452423
• Report Number: 3006630150-2024-00011
• Device Sequence Number: 17882378
• Product Code: GXI
• UDI-Device Identifier: 00813250014365
• UDI-Public: 00813250014365
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082012
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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: TCD-10-3M
• Device Catalogue Number: TCD-10-3M
• Device Lot Number: 31696355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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