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

Model Number	RLV 0055
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an intracept procedure, the physician made multiple attempts to troubleshoot hitting the target by removing the j-stylet multiple times to insert the probe.When the curved cannula was removed, the tip of the peek was sheared off.It could not be confirmed whether the device fragment was contained inside or outside the bone.The procedure was completed as scheduled and the patient was doing well postoperatively.
Additional Manufacturer Narrative
The intercept curved cannula was returned and analyzed.A visual inspection revealed that the curved cannula shaft tip was broken.The breakage of the curved cannulas shaft tip was likely due to use of excessive force during the procedure.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 the probe.It also states that breakage, slippage, misuse or mishandling of instruments or the 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.
Event or Problem Description
It was reported that during an intercept procedure, the physician made multiple attempts to troubleshoot hitting the target by removing the j-stylet multiple times to insert the probe.When the curved cannula was removed, the tip of the peek was sheared off.It could not be confirmed whether the device fragment was contained inside or outside the bone.The procedure was completed as scheduled 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 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: 22929344
• Report Number: 3006630150-2025-07065
• Device Sequence Number: 10294349
• Product Code: GXI
• UDI-Device Identifier: 00852454006226
• UDI-Public: (01)00852454006226(17)270130(10)36201850
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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 Model Number: RLV 0055
• Device Catalogue Number: RLV 0055
• Device Lot Number: 36201850
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Race: White