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

Model Number	FG0060
Medical Device Problem Codes	Material Fragmentation (1261); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned curved cannulas were analyzed and the complaints were confirmed.Curved cannula 1 was found to be deformed and the peek lumen was separated below the handle.The location where the lumen broke and handle separation showed signs of excessive force.Based on the complaint description, it is inferred that the curved cannula was used beyond its intended use.Curved cannula 2 was visibly deformed at the distal end where the peek material is.The peek material appears to be sheared off.This type of failure is consistent with the description of the physician using excessive force and twisting the assembly to remove the instrument.Introducer cannulas were returned were found bent which is consistent with use in hard bone.The returned straight stylet was also bent at the distal end.
Event or Problem Description
It was reported that during an intracept procedure, the procedure faced issues with high impedance on the original probe at the l5 vertebral body on both sides.The probe was switched out with a new one.Despite clearing the tract and using a new probe the high impedances occurred again but on the right side of l5.The curved cannula also became stuck in l5, requiring force and twisting in order to remove.The patient's bone was notably hard.The peek material of the curved cannula sheared off in the left side of l5.A new curved cannula was used to access the right side l5, it also seemed stuck and eventually broke at the proximal end but was fully retrieved with hemostats.The patient's bone on this side was not as hard but dense.There were no device fragments left inside the patient.Due to these complications, l5 was not ablated, and l4 was not attempted.The procedure was aborted.The patient had no reported complaints before discharge.

• 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: 21368070
• Report Number: 3006789852-2025-00019
• Device Sequence Number: 18283804
• Product Code: GXI
• UDI-Device Identifier: 00852454006189
• UDI-Public: 00852454006189
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170827
• 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: 10/13/2025
• Device Model Number: FG0060
• Device Catalogue Number: FG0060
• Device Lot Number: 127328623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• 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: 10/13/2023
• 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: 52 YR
• Patient Sex: Female
• Patient Race: White