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

Model Number	RLV 0045
Medical Device Problem Codes	Material Fragmentation (1261); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an intracept procedure, the physician encountered very hard bone and it was difficult to get the stylet into the cannula.When the physician attempted to take everything out, he noticed that the peek of the curved cannula was missing and the curved cannula assembly was not seamlessly fitting together.It was noted that a small part of the peek was left behind inside the patient and it is unknown if it was left inside the bone or outside the bone.The issue arose on the first level and there were no patient complications.The devices were discarded by the facility and will not be returned for device analysis.
Additional Manufacturer Narrative
The devices were not returned for analysis as they were discarded by the medical facility, therefore, a physical analysis has not been conducted in our laboratory.A product labeling review identified that the devices were used per the (ifu) product label a labeling review did not reveal any anomalies as it states that breakage, slippage, misuse or mishandling of instruments or probe, such as on sharp edges, may cause burns or injury to the patient or operative personnel is a potential adverse event associated with the use of the intracept intraosseous nerve ablation system.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.The devices were not returned for analysis as they were discarded by the medical facility.In addition, physical analysis has not been conducted in our laboratory.However, the labeling review was conducted.With the reported observations and the labeling review, it has been determined that the sheared peek on the curved cannula is a known inherent risk with use of the device as documented in the ifu.
Event or Problem Description
It was reported that during an intracept procedure, the physician encountered very hard bone and it was difficult to get the stylet into the cannula.When the physician attempted to take everything out, he noticed that the peek of the curved cannula was missing and the curved cannula assembly was not seamlessly fitting together.It was noted that a small part of the peek was left behind inside the patient and it is unknown if it was left inside the bone or outside the bone.The issue arose on the first level and there were no patient complications.The devices were discarded by the facility and will not be returned for device analysis.

• 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: 24171707
• Report Number: 3006630150-2026-00494
• Device Sequence Number: 15968912
• Product Code: GXI
• UDI-Device Identifier: 00852454006301
• UDI-Public: (01)00852454006301(17)270807(10)37876715
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 04/13/2026

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: 37876715
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 04/13/2026
• Date Device Manufactured: 08/07/2025
• 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