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

Model Number	RLV 0065
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a basivertebral nerve (bvn) radiofrequency ablation (rfa) procedure, the bevel introducer cannula fractured while being advanced into the first vertebral body.The physician was malleting the introducer cannula when the clip on the bevel introducer cannula broke.It is unknown whether any fragmented material remained within the patient or if it was contained within the vertebral body.An additional device was used to complete the procedure.The patient is doing well, and no adverse effects were reported.The device is expected to be returned for analysis.
Event or Problem Description
It was reported that during a basivertebral nerve (bvn) radiofrequency ablation (rfa) procedure, the bevel introducer cannula fractured while being advanced into the first vertebral body.The physician was malleting the introducer cannula when the clip on the bevel introducer cannula broke.It is unknown whether any fragmented material remained within the patient or if it was contained within the vertebral body.An additional device was used to complete the procedure.The patient is doing well, and no adverse effects were reported.The device is expected to be returned for analysis.\ \ additional information was received stating that the fractured component was completely removed.The fracture was located at the top of the t handle body.No fragmented material remained within the patient.

• 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; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50697506
• Report Number: 3006630150-2026-06624
• Device Sequence Number: 13182833
• Product Code: GXI
• UDI-Device Identifier: 00852454006424
• UDI-Public: (01)00852454006424(17)280608(10)39692321
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 09/22/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: RLV 0065
• Device Catalogue Number: RLV 0065
• Device Lot Number: 39692321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/09/2026
• Supplement Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 06/09/2026
• 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
• Patient Age: 61 YR
• Patient Sex: Male