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

Model Number	RLV 0015
Medical Device Problem Codes	Failure to Deliver Energy (1211); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Respiratory Insufficiency (4462); Insufficient Information (4580)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure, the patient was sedated under monitored anesthesia care (mac).It was noted that the patient had a big belly and hard time breathing.The patient was flipped over and the physician decided to abort the case.The patient was stable postoperatively and there were no further issues.
Additional Manufacturer Narrative
At this time the returned device is currently undergoing technical analysis and the investigation is not yet complete.
Event or Problem Description
It was reported that during a procedure, the patient was sedated under monitored anesthesia care (mac).It was noted that the patient had a big belly and hard time breathing.The patient was flipped over and the physician decided to abort the case.There was also an issue with the probe not being recognized by the generator, so a second probe was opened.However, no ablation was performed prior to the aborted procedure.The probe issue was not related to the cause of the aborted procedure.The patient was stable postoperatively and there were no further issues.
Additional Manufacturer Narrative
The returned probe was analyzed, however, the technical analysis was unable to confirm the reported observation with testing of the product return.The probe placement was detected when connected into both the generator and the phantom gel.A simulated ablation was completed without any anomalies.The probe exhibits normal characteristics.
Event or Problem Description
It was reported that during a procedure, the patient was sedated under monitored anesthesia care (mac).It was noted that the patient had a big belly and hard time breathing.The patient was flipped over and the physician decided to abort the case.There was an issue with the probe not being recognized by the generator, so a second probe was opened.However, no ablation was performed prior to the aborted procedure.The patient was stable postoperatively and there were no further issues.

• 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): RELIEVANT MEDSYSTEMS, INC.; 7201 metro blvd ste 300,; mn 55439; edina MN 55439
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 21845084
• Report Number: 3006630150-2025-02501
• Device Sequence Number: 18466841
• Product Code: GXI
• UDI-Device Identifier: 00852454006219
• UDI-Public: (01)00852454006219(17)260904(10)109168858
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/24/2025

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 Expiration Date: 09/04/2026
• Device Model Number: RLV 0015
• Device Catalogue Number: RLV 0015
• Device Lot Number: 109168858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 05/13/2025; 06/27/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 06/11/2025; 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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: Required Intervention
• Patient Sex: Unknown