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 Code	Aspiration/Inhalation (1725)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the intracept procedure, the first ablation at l3 was completed without issue.The second level was then started at l4, and ablation had been underway for less than two minutes when the patient began to aspirate.The physician immediately stopped the ablation and removed the intracept instruments.The anesthesia team provided suction to clear the airway.The patient had been under monitored anesthesia care (mac) using propofol as the sole sedative.The physician does not believe the aspiration event was caused by the intracept device or the procedure itself.When emergency services arrived, the patient was awake, speaking, and breathing independently.The cause of the patient's complications is unknown.No further information has been obtained despite good faith efforts.The devices were discarded by the medical facility.
Additional Manufacturer Narrative
A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.The devices were discarded by the medical facility.As such, physical analysis has not been conducted in our laboratory.Based on limited information and in the absence of device return, the root cause of the reported event of patient aspirating cannot be established as the product has not been returned for analysis.
Event or Problem Description
It was reported that during the intracept procedure, the first ablation at l3 was completed without issue.The second level was then started at l4, and ablation had been underway for less than two minutes when the patient began to aspirate.The physician immediately stopped the ablation and removed the intracept instruments.The anesthesia team provided suction to clear the airway.The patient had been under monitored anesthesia care (mac) using propofol as the sole sedative.The physician does not believe the aspiration event was caused by the intracept device or the procedure itself.When emergency services arrived, the patient was awake, speaking, and breathing independently.The cause of the patient's complications is unknown.No further information has been obtained despite good faith efforts.The devices were discarded by the medical facility.

• Brand Name: INTRACEPT
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): RELIEVANT MEDSYSTEMS, INC.; 1230 midas way suite 200; sunnyvale 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: 24533638
• Report Number: 3006630150-2026-01326
• Device Sequence Number: 10458321
• Product Code: GXI
• UDI-Device Identifier: 00852454006226
• UDI-Public: (01)00852454006226(17)270825(10)38196328
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: 38196328
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/16/2026
• Date Device Manufactured: 08/25/2025
• 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: Other
• Patient Age: 63 YR
• Patient Sex: Unknown