MAUDE Adverse Event Report: RELIEVANT MEDSYSTEMS, INC. INTRACEPT; PROBE, RADIOFREQUENCY LESION

Model Number	RLV 0045
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Air Embolism (1697); Foreign Body In Patient (2687)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the during the intracept procedure, the physician encountered hard bone.When the physician removed the curved cannula, he noticed that the tip was broken.The broken device fragment was unable to be retrieved during the procedure, and it could not be confirmed that the device fragment was contained inside the bone via fluoroscopy.An additional kit was opened and the procedure was completed successfully.It was also noted that the patient experienced air embolism during the procedure.
Event or Problem Description
It was reported that the during the intracept procedure, the physician encountered hard bone.When the physician removed the curved cannula, he noticed that the tip was broken.The broken device fragment was unable to be retrieved during the procedure, and it could not be confirmed that the device fragment was contained inside the bone via fluoroscopy.An additional kit was opened and the procedure was completed successfully.It was also noted that the patient experienced air embolism during the procedure.Additional information was received that the patient did not experience any complications including air embolism.
Additional Manufacturer Narrative
This report is report is being submitted to correct the impact code description, impact code field (h6) in section h, device manufacturers only.
Event or Problem Description
It was reported that the during the intercept procedure, the physician encountered hard bone.When the physician removed the curved cannula, he noticed that the tip was broken.The broken device fragment was unable to be retrieved during the procedure, and it could not be confirmed that the device fragment was contained inside the bone via fluoroscopy.An additional kit was opened and the procedure was completed successfully.It was also noted that the patient experienced air embolism during the procedure.Additional information was received that the patient did not experience any complications including air embolism.

• Brand Name: INTRACEPT
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): RELIEVANT MEDSYSTEMS, INC.; 1230 midas way suite 200; sunnyvale CA 94085
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 7201 metro blvd ste 300; edina MN
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22146967
• Report Number: 3006630150-2025-03968
• Device Sequence Number: 12725120
• Product Code: GXI
• UDI-Device Identifier: 00852454006301
• UDI-Public: (01)00852454006301(17)261212(10)35788378
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K222281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2025

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: RLV 0045
• Device Catalogue Number: RLV 0045
• Device Lot Number: 35788378
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 08/01/2025; 09/25/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 08/08/2025; 10/23/2025
• Date Device Manufactured: 12/12/2024
• 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: Male