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

Model Number	RLV 0055
Medical Device Problem Codes	Material Fragmentation (1261); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician encountered hard bone during the procedure.For each level that was accessed, the curved cannula peek came out kinked on the bottom.L5 had to be accessed on both sides due to hard bone and all three curved cannulas were sheared due to hard bone at the previous three levels.In addition, the latch broke off the curved cannula assembly on the fourth pedicle access.An x-ray was performed, but it could not be confirmed whether or not the sheared peek was left behind inside the patient.The procedure was completed successfully.
Additional Manufacturer Narrative
A visual inspection revealed that the curved cannula handle was broken from the screw threads.The shaft tip of all three curved cannulas were damaged.The bevel stylet and introducer cannula passed a visual inspection.
Event or Problem Description
It was reported that the physician encountered hard bone during the procedure.For each level that was accessed, the curved cannula peek came out kinked on the bottom.L5 had to be accessed on both sides due to hard bone and all three curved cannulas were sheared due to hard bone at the previous three levels.In addition, the latch broke off the curved cannula assembly on the fourth pedicle access.An x-ray was performed, but it could not be confirmed whether or not the sheared peek was left behind inside the patient.The procedure was completed successfully.

• 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): 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: 21521309
• Report Number: 3006630150-2025-01219
• Device Sequence Number: 12845662
• Product Code: GXI
• UDI-Device Identifier: 00852454006226
• UDI-Public: 00852454006226
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/05/2025

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 Expiration Date: 09/06/2026
• Device Model Number: RLV 0055
• Device Catalogue Number: RLV 0055
• Device Lot Number: 818773
• 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: 02/07/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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
• Patient Sex: Unknown