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

Model Number	RLV 0065
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received without sufficient documentation to confirm its origin.As a result, no further details could be obtained from the field to support additional investigation.
Event or Problem Description
Device analysis performed on the returned curved cannula1 confirmed that the shaft tip was sheared.The damage observed is consistent with the application of excessive force during the procedure.With the available information, technicians assessed this event is attributed to an unintended use error.A labeling review did not reveal any anomalies and states that 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.Labeling also 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 risk review was completed and confirmed that the event of unretrieved device fragments (udf) 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.

• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24634829
• Report Number: 3006630150-2026-01609
• Device Sequence Number: 15602504
• Product Code: GXI
• UDI-Device Identifier: 00852454006424
• UDI-Public: (01)00852454006424(17)271113(10)38166824
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

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 0065
• Device Catalogue Number: RLV 0065
• Device Lot Number: 38166824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown