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

Model Number	RLV 0075
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a basivertebral nerve (bvn) ablation procedure, the physician encountered hard bone at l5 and when he took everything out at once at the end after the burn, he found that the peak sheath was shredded at the end.New product was then used to replace the peak sheath and procedure was completed as planned.It was not able to be confirmed if the broken piece was left inside the bone or not and was not visible on x-ray.Post operatively, there were no complications reported and the patient was stable.The used product will not be returned as it was retained by the customer.

• 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: 50263444
• Report Number: 3006630150-2026-05931
• Device Sequence Number: 13323802
• Product Code: GXI
• UDI-Device Identifier: 00852454006257
• UDI-Public: (01)00852454006257(17)280109(10)38803060
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K222281
• 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): 09/18/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: RLV 0075
• Device Catalogue Number: RLV 0075
• Device Lot Number: 38803060
• 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: 07/23/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 01/09/2026
• 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: Other
• Patient Age: 52 YR
• Patient Sex: Male