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 Code	Foreign Body In Patient (2687)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an intracept procedure, there were issues with inserting the probe inside the curved cannula.It was noticed that the curved cannula had a sheared peek at the distal tip.An additional intracept kit was opened to successfully complete the procedure.The curved cannula was flushed out, but the sheared peak did not come out.Only clotted blood came out, which was noted as normal for this procedure.It is unknown if the sheared peek was still within the bone or inside the patient.The sheared peek was not seen on any imaging that was taken during the procedure.In addition, four levels were completed before the issue occurred and it was noted that some hard bone was encountered during the procedure.
Additional Manufacturer Narrative
The device was not returned for analysis and the complaint as reported was not able to be confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A risk review was completed and confirmed that the event of sheared peek - distal tip was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.With all the available information, boston scientific concludes that the reported event of the curved cannula sheared peek at the distal tip being left behind inside the patient could not be confirmed.It could not be confirmed whether the device fragment was contained inside the bone or outside the bone.Record review revealed no additional information related to the complaint.Therefore, this investigation is unable to determine a probable cause for the complaint.
Event or Problem Description
It was reported that during an intracept procedure, there were issues with inserting the probe inside the curved cannula.It was noticed that the curved cannula had a sheared peek at the distal tip.An additional intracept kit was opened to successfully complete the procedure.The curved cannula was flushed out, but the sheared peak did not come out.Only clotted blood came out, which was noted as normal for this procedure.It is unknown if the sheared peek was still within the bone or inside the patient.The sheared peek was not seen on any imaging that was taken during the procedure.In addition, four levels were completed before the issue occurred and it was noted that some hard bone was encountered during the procedure.

• 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: 23855904
• Report Number: 3006630150-2025-11571
• Device Sequence Number: 5030676
• Product Code: GXI
• UDI-Device Identifier: 00852454006301
• UDI-Public: (01)00852454006301(17)270701(10)37434286
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: RLV 0045
• Device Catalogue Number: RLV 0045
• Device Lot Number: 37434286
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/25/2026
• Date Device Manufactured: 07/01/2025
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Race: White