MAUDE Adverse Event Report: Relievant Medsystems, Inc. Intracept; Probe, Radiofrequency Lesion

Model Number	RLV 0045
Medical Device Problem Codes	Material Fragmentation (1261); Difficult to Remove (1528); Material Integrity Problem (2978); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Inflammation (1932); Pain (1994); Anxiety (2328); Foreign Body In Patient (2687); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a level three intracept procedure and the j-stylet and curved cannula peek broke off into the pedicle and vertebra during the procedure.The procedure was performed without difficulty, however, when the j-stylet was removed from the patient, the curved cannula peek was embedded in the l5 vertebral body and right l5 pedicle.The patient reported experiencing a new pain syndrome since the procedure.The patient feels that the left-sided symptoms have improved.The physician stated that the majority of the patients right sided low back, buttock and thigh pain is secondary to her acute right l5 transverse process fracture.The patient continues to have back pain from the incision site but it seems to be improving with time.The patient is experiencing pain shooting down her right leg that seems to be new and different from her regular back pain.The pain is intermittent in nature and it is a sharp, stabbing sensation that radiates along the posterolateral thigh to the level of the calf.The patient rates her pain as moderate to severe in intensity.An x-ray of the lumbar spine was performed and confirmed the device fragment from the intracept procedure is localized to the right pedicle and vertebral body.Additionally, a computed tomography (ct) scan was performed and confirmed the mildly displaced acute fracture of the right l5 transverse process.The physician stated that it is very unlikely that the transverse process fracture is contributing to the patients radicular symptoms.
Additional Manufacturer Narrative
A j stylet and two curved cannulas of the kit were returned for analysis.A visual inspection of the j stylet revealed that the tip was broken.A visual inspection of the first curved cannula found that the peek shaft was broken at the tip.The second curved cannula passed a visual inspection.A labeling review did not reveal any anomalies as it 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 failure.It also states that breakage, slippage, misuse or mishandling of instruments or probe, such as on sharp edges, may cause burns or injury to the patient or operative personnel is a known risk associated with the use of the intracept intraosseous nerve ablation system.A risk review was completed and confirmed that the event of sheared peek distal tip was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The allegation of the broken j stylet and curved cannula was confirmed.The damaged instruments were likely due to use of excessive force during the procedure.Therefore, this investigation will be assigned a probable cause of unintended use error caused or contributed to event.

• 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: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25899509
• Report Number: 3006630150-2026-05216
• Device Sequence Number: 8734113
• Product Code: GXI
• UDI-Device Identifier: 00852454006301
• UDI-Public: 00852454006301
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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 0045
• Device Catalogue Number: RLV 0045
• Device Lot Number: 35538112
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 37 YR
• Patient Sex: Female