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

Model Number	RLV 0055
Medical Device Problem Codes	Nonstandard Device (1420); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the intercept procedure, the physician encountered very hard bone.While malleting the introducer cannula with the diamond stylet, the stylet kept popping up from the introducer cannula and ended up breaking.The stylet would no longer click into the introducer cannula.The same issue also occurred with the bevel stylet.It was noted that one of the t-handles on the introducer cannula started splitting apart.A new kit was opened and a new diamond stylet and bevel stylet were used to complete the procedure.The introducer cannula, diamond stylet, and two curved cannulas were returned for analysis.A visual inspection revealed that one introducer cannula handle was slightly split between the dark and light gray plastic and the second introducer cannula handle latch was broken.It was found that the diamond stylet latch was broken and two curved cannula tips were sheared.The bevel stylet was not returned for analysis.It could not be confirmed if any device fragments were left behind inside 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; 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: 22890322
• Report Number: 3006630150-2025-06873
• Device Sequence Number: 4915464
• Product Code: GXI
• UDI-Device Identifier: 00852454006226
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K222281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/14/2026

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 0055
• Device Catalogue Number: RLV 0055
• Device Lot Number: 36306158
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2025
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 03/11/2025
• 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
• Patient Sex: Unknown