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 Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a curved cannula was returned for an unknown reason and visual inspection revealed that the curved cannula shaft tip was broken.The j- stylet was tested with a known good curved cannula and introducer cannula and revealed that it lacks any extreme resistance and locked during the functional test.A product labeling review identified that the device was used per the instructions for use (ifu) product label.Additionally, the ifu 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 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.Technicians confirmed through visual inspection that the curved cannula shaft tip was broken.Therefore, based on the available information and product labelling review, it has been determined that the probable cause was unintended use error caused or contributed to event.The damage was likely due to the use of excessive force during the procedure.
Event or Problem Description
It was reported that a curved cannula was returned for an unknown reason and visual inspection revealed that the curved cannula shaft tip was broken.The j- stylet was tested with a known good curved cannula and introducer cannula and revealed that it lacks any extreme resistance and locked during the functional test.A product labeling review identified that the device was used per the instructions for use (ifu) product label.Additionally, the ifu 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 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.Technicians confirmed through visual inspection that the curved cannula shaft tip was broken.Therefore, based on the available information and product labelling review, it has been determined that the probable cause was unintended use error caused or contributed to event.The damage was likely due to the use of excessive force during the procedure.

• 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: 24780604
• Report Number: 3006630150-2026-02033
• Device Sequence Number: 13237723
• Product Code: GXI
• UDI-Device Identifier: 00852454006424
• UDI-Public: (01)00852454006424(17)271113(10)38166826
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2026

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: 38166826
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/27/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/06/2026; 08/04/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/01/2026; 08/24/2026
• 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
• Patient Sex: Unknown