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

Model Number	RLV 0055
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Fluid Discharge (2686)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an intracept procedure, the patient had fluids coming out of him.The patient was under anesthesia when the physician decided to abort the procedure due to the patient aspirating.As a result, 911 was called for the patient.The physician assessed the event as not related to the device or the procedure, as the patient's issues did not involve the tools or the intracept procedure.The cause of the patient's complications and the patient's current status is unknown.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
The device was not returned for analysis.As such, physical analysis has not been conducted in our laboratory.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Per the ifu, it states that improper surgical use and technique may lead to suboptimal clinical outcomes.A risk review was completed and confirmed that the event of aspiration 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 device was not returned for analysis.However, a labelling review found that the reported event is a known risk associated with the use of the intracept intraosseous nerve ablation system.Therefore, this event is assigned a probable cause of known inherent risk of device.
Event or Problem Description
It was reported that during an intracept procedure, the patient had fluids coming out of him.The patient was under anesthesia when the physician decided to abort the procedure due to the patient aspirating.As a result, 911 was called for the patient.The physician assessed the event as not related to the device or the procedure, as the patients issues did not involve the tools or the intracept procedure.The cause of the patients complications and the patients current status is unknown.No further information has been obtained despite good faith efforts.

• 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 sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24242801
• Report Number: 3006630150-2026-00664
• Device Sequence Number: 13254581
• Product Code: GXI
• UDI-Device Identifier: 00852454006226
• UDI-Public: (01)00852454006226(17)270815(10)37930764
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: RLV 0055
• Device Catalogue Number: RLV 0055
• Device Lot Number: 37930764
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 04/22/2026
• Date Device Manufactured: 08/15/2025
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Other
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Race: Black Or African American