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

Model Number	RLV 0065
Medical Device Problem Codes	Material Fragmentation (1261); Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on limited information and in the absence of the device return, the root cause of difficulty removing the cannula, resulting in the sheared peek, was unable to be established.The device was not returned for analysis, as such, physical analysis has not been conducted in our laboratory.However, media inspection of the device confirmed that the cannula fractured.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process-related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specifications prior to release for use.There is no indication that the device manufacturing process contributed to the reported complaint.A risk review of the intracept access instruments 2 vb hazard analysis was completed and confirmed that the event of sheared peek - distal tip was defined in the risk documentation.This event type has been accounted for during product risk analysis to support an acceptable risk-benefit for the product.The device was not returned for analysis; however, evaluation of the available media displayed that the cannula had fractured.A review of the manufacturing records revealed no additional information relevant to the event.Consequently, the probable cause of difficulty removing the cannula, resulting in the sheared peek could not be determined.
Event or Problem Description
It was reported that during a radiofrequency ablation (rfa) procedure, the procedure went as planned until the removal of the curved cannula at the end of the procedure.The curved cannula became hooked on hard bone in the vertebral body and stretched when pulling out.During troubleshooting attempts to remove the cannula, it fractured.A second physician was called in to perform an additional dissection down to the pedicle to access and remove the peek component.A portion of the peek material remains within the bone.The procedure was completed and the patient was doing well postoperatively.

• 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): 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: 25075682
• Report Number: 3006630150-2026-02879
• Device Sequence Number: 10418307
• Product Code: GXI
• UDI-Device Identifier: 00852454006424
• UDI-Public: (01)00852454006424(17)280128(10)38708721
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: RLV 0065
• Device Catalogue Number: RLV 0065
• Device Lot Number: 38708721
• 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: 04/08/2026
• Initial Report FDA Received Date: 05/04/2026
• Date Device Manufactured: 01/28/2026
• 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: Female