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

Model Number	RLV 0045
Medical Device Problem Codes	Difficult to Remove (1528); Defective Device (2588)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an intracept procedure, hard bone was encountered at the l5 lumbar vertebrae.During the deployment of the curved cannula assembly, the instrument appeared to turn posterior in the vertebral bone.The physician attempted to remove the curved cannula assembly and go back in with a straight stylet.However, it was difficult for the physician to pull out the curved cannula assembly.After a lot of force, the curved cannula assembly was eventually removed.The end of the curved cannula appeared to be a little beaten up and the physician decided not to continue using the original curved cannula.After driving deeper into the vertebral bone using the straight stylet, the second curved cannula assembly was deployed.The physician was not able to advance the probe completely across the spinous process, so the physician attempted to remove the probe.The probe appeared to be stuck but was able to be completely removed by the physician.The generator displayed an impedance error when the physician attempted to start a burn.The issue was resolved with a new probe and the case was completed successfully.The patient was doing well postoperatively.Two curved cannulas were returned and analyzed.A visual inspection revealed that the curved cannula shaft tip was damaged.In addition, the second curved cannula shaft tip was sheared.Since the boston scientific representative was not aware that the curved cannula peek was sheared during the procedure, it could not be confirmed if any device fragments were left behind inside the patient, or if any device fragments were contained inside the bone.

• 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: 22135383
• Report Number: 3006630150-2025-03905
• Device Sequence Number: 18235404
• Product Code: GXI
• UDI-Device Identifier: 00852454006301
• UDI-Public: 00852454006301
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 06/03/2025

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: 09/23/2026
• Device Model Number: RLV 0045
• Device Catalogue Number: RLV 0045
• Device Lot Number: 818777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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 Age: 49 YR
• Patient Sex: Female
• Patient Race: Black Or African American