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

Model Number	RLV 0055
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	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an intercept procedure that the physician encountered hard bone and while intercept the bevel stylet and introducer cannula, part of the blue plastic broke off the top of the bevel stylet.The broken piece was not inside the patient.The physician switched to a diamond stylet and when the curved cannula assembly was removed, he noticed that part of the peek broke off the distal end.It is likely that some of the peek was left behind inside the patient.Since no device fragments were visible on the x-ray, it could not be confirmed whether there were device fragments contained inside or outside the bone.The procedure was completed as usual.
Event or Problem Description
It was reported that during an intracept procedure that the physician encountered hard bone and while malleating the bevel stylet and introducer cannula, part of the blue plastic broke off the top of the bevel stylet.The broken piece was not inside the patient.The physician switched to a diamond stylet and when the curved cannula assembly was removed, he noticed that part of the peek broke off the distal end.It is likely that some of the peek was left behind inside the patient.Since no device fragments were visible on the x-ray, it could not be confirmed whether there were device fragments contained inside or outside the bone.The procedure was completed as usual.
Additional Manufacturer Narrative
The curved cannula, bevel stylet, and j-stylet were returned and analyzed.A visual inspection revealed that the curved cannula shaft tip was sheared.The bevel stylet latch and the handle were broken.The j-stylet was tested with a known good curved cannula and a known good introducer cannula.The results showed that the j-stylet lacks any extreme resistance and locked during the functional test.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.

• 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: 23640765
• Report Number: 3006630150-2025-10780
• Device Sequence Number: 13189801
• Product Code: GXI
• UDI-Device Identifier: 00852454006226
• UDI-Public: (01)00852454006226(17)270612(10)37143683
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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 0055
• Device Catalogue Number: RLV 0055
• Device Lot Number: 37143683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• 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: 48 YR
• Patient Sex: Unknown