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

Model Number	RLV 0065
Medical Device Problem Codes	Material Fragmentation (1261); Nonstandard Device (1420); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an intracept procedure, there was tension when the physician placed the j-stylet in the correct position.When the curved cannula assembly was removed, the peek was missing.This happened to both curved cannulas in the same kit.It was noted that there was peek overdrive where the peek became rigid and torn after one level was completed.A bit of the peek was broken off when the physician tried to wheel up the j-stylet into the curved cannula assembly and it was left inside the patient.It is unknown if the device fragment was contained inside or outside the bone.There were no patient complications.
Additional Manufacturer Narrative
The intracept access kit was returned and a visual inspection revealed that both curved cannula shaft tips were broken and the straight stylet shaft was damaged.The bevel stylet, the diamond stylet, and the j-stylet were each tested with a known good introducer cannula and revealed that they lacked any extreme resistance and locked during the functional test.The two introducer cannulas were tested with a known good bevel stylet and the test revealed that they lacked any extreme resistance and locked during the functional test.A labeling review did not reveal any anomalies as it states that in the event of inadvertent advancement of the introducer cannula during deployment of the curved cannula assembly, care must be taken to prevent potential further device damage.This can occur if mallet strikes continue to be delivered when the gear wheel is in contact with the introducer cannula.This scenario can create a condition in which the introducer cannula advances along its straight trajectory, while the curved cannula is held in the bone along its curved trajectory.This can lead to the creation of a kink in the curved cannula material.If it is suspected that this occurred, or if retraction of the curved cannula is difficult, it is recommended that introducer cannula and curved cannula be removed as a single unit, rather than retracting the curved cannula by itself.A labeling review also states that as with any surgical instrument, careful attention must be exercised to ensure that excessive force is not placed on the instruments or probe.Excessive force can result in product issues.A risk review 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 acceptable risk benefit for the product.The event of the missing peek on the curved cannulas was confirmed.The two curved cannula shaft tips were broken and the straight stylet shaft pebax was damaged.The breakage and the damage were likely due to use of excessive force during the procedure.The bevel stylet, the diamond stylet, the two introducer cannulas, and the j-stylet exhibit normal functionalities.
Event or Problem Description
It was reported that during an intracept procedure, there was tension when the physician placed the j-stylet in the correct position.When the curved cannula assembly was removed, the peek was missing.This happened to both curved cannulas in the same kit.It was noted that there was peek overdrive where the peek became rigid and torn after one level was completed.A bit of the peek was broken off when the physician tried to wheel up the j-stylet into the curved cannula assembly and it was left inside the patient.It is unknown if the device fragment was contained inside or outside the bone.There were no patient complications.

• Brand Name: INTRACEPT
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): RELIEVANT MEDSYSTEMS, INC.; 1230 midas way suite 200; sunnyvale CA 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: 24063777
• Report Number: 3006630150-2026-00319
• Device Sequence Number: 21403223
• Product Code: GXI
• UDI-Device Identifier: 00852454006424
• UDI-Public: (01)00852454006424(17)270925(10)37930775
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 03/10/2026

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 Model Number: RLV 0065
• Device Catalogue Number: RLV 0065
• Device Lot Number: 37930775
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• 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: Female
• Patient Race: White