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

Model Number	RLV 0065
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a basivertebral nerve (bvn) radiofrequency ablation (rfa) procedure, the patient experienced bleeding upon removal of the access cannula.The patient had a history of scoliosis, and the physician initially docked using an anteroposterior (ap) approach on the lateral aspect of the pedicle.Subsequent lateral imaging indicated that the cannula was positioned further into the pedicle than originally suspected and may have been in a parapedicular or extrapedicular location.The physician continued advancement with a mallet but determined that the cannula was too loose to safely proceed.The physician elected to return to the ap view and establish a new docking point.Upon removal of the access cannula, a large volume of blood was observed exiting the cannula.The physician indicated that the bleeding may have been associated with injury to an arterial blood vessel.The procedure was aborted at that time.The patient was reported to be doing well following the event.The device was retained and is not expected to be returned for analysis.

• 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: 50871267
• Report Number: 3006630150-2026-07030
• Device Sequence Number: 21511736
• Product Code: GXI
• UDI-Device Identifier: 00852454006424
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/23/2026

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: 85038909
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 06/29/2026
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 154 LB