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

Model Number	RLV0045
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was confirmed.The returned curved cannula was analyzed and found that the distal tip was sheared off.
Event or Problem Description
It was reported that during an intercept procedure while the physician had difficulty removing the j-stylet.The physician tried to pry and ratchet the j-stylet out but eventually removed the assembly with the curved cannula.When the entire assembly was removed it was noticed that 2-3mm of peek material was sheared off from the curved cannula inside the patient.Based on the available information, bsc could not confirm the location of the device fragment.It was noted that the patient had hard bone.The procedure was completed successfully.

• Brand Name: INTRACEPT
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): RELIEVANT MEDSYSTEMS; 1230 midas way; suite 200; sunnyvale CA 94085 4068
• Manufacturer (Section G): RELIEVANT MEDSYSTEMS, INC.; 7201 metro blvd.; ste 300; edina MN 55439
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 21366191
• Report Number: 3006789852-2025-00005
• Device Sequence Number: 8416542
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2025

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: 04/15/2026
• Device Model Number: RLV0045
• Device Catalogue Number: RLV0045
• Device Lot Number: 740506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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