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

Model Number	RLV 0015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Airway Obstruction (1699); Insufficient Information (4580)
Date of Event	06/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an intracept procedure, the patient's airway became compromised and the patient needed to be flipped back supine to restore their airway.The procedure was aborted and rescheduled at a later date.The patient was sedated with general anesthesia.The physician assessed the event as not being related to the device or the procedure.There were no patient complications.
Event or Problem Description
It was reported that during an intracept procedure, the patient's airway became compromised and the patient needed to be flipped back supine to restore their airway.The procedure was aborted and rescheduled at a later date.The patient was sedated with general anesthesia.The physician assessed the event as not being related to the device or the procedure.There were no patient complications.Additional information was received that the laryngeal mask airway (lma) was pulled back because it was not secured properly and needed to be repositioned.
Additional Manufacturer Narrative
This report is being submitted to correct the race field (a6) in section a, patient information, the outcomes attributed to adverse event field (b2) in section b, adverse event/product problem, and the impact code description, impact code field (h6) in section h, device manufacturers only.
Event or Problem Description
It was reported that during an intercept procedure, the patients airway became compromised and the patient needed to be flipped back supine to restore their airway.The procedure was aborted and rescheduled at a later date.The patient was sedated with general anesthesia.The physician assessed the event as not being related to the device or the procedure.There were no patient complications.Additional information was received that the laryngeal mask airway (lma) was pulled back because it was not secured properly and needed to be repositioned.

• Brand Name: INTRACEPT RF PROBE
• 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: 22377568
• Report Number: 3006630150-2025-05042
• Device Sequence Number: 14556248
• Product Code: GXI
• UDI-Device Identifier: 00852454006219
• UDI-Public: (01)00852454006219(17)261211(10)36576166
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180369
• 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): 10/21/2025

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 0015
• Device Catalogue Number: RLV 0015
• Device Lot Number: 36576166
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 09/23/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/25/2025; 10/21/2025
• Date Device Manufactured: 12/11/2024
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Race: White