MAUDE Adverse Event Report: RELIEVANT MEDSYSTEMS, INC. INTRACEPT; PROBE, RADIOFREQUENCY LESION

Model Number	RLV 0045
Medical Device Problem Codes	Difficult to Remove (1528); 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	03/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the intracept procedure, the physician had difficulties removing the j-stylet from the curved cannula due to very hard bone.The physician began to twist and pull extremely hard while holding both the j-stylet and the curved cannula.This caused the top of the curved cannula to snap off when the j-stylet was removed.However, this did not cause any issues with completing the lesion and the physician stated that the instrument broke due to him putting a tremendous amount of force on it.The broken curved cannula was returned and analyzed.Visual inspection revealed that the curved cannula handle was broken off from the screw threads and the shaft tip was sheared.It could not be confirmed if any device fragments were left behind inside the patient and whether or not they were contained inside the bone.
Event or Problem Description
It was reported that during the intracept procedure, the physician had difficulties removing the j-stylet from the curved cannula due to very hard bone.The physician began to twist and pull extremely hard while holding both the j-stylet and the curved cannula.This caused the top of the curved cannula to snap off when the j-stylet was removed.However, this did not cause any issues with completing the lesion and the physician stated that the instrument broke due to him putting a tremendous amount of force on it.The broken curved cannula was returned and analyzed.Visual inspection revealed that the curved cannula handle was broken off from the screw threads and the shaft tip was sheared.It could not be confirmed if any device fragments were left behind inside the patient and whether or not they were contained inside the bone.

• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22133448
• Report Number: 3006630150-2025-03897
• Device Sequence Number: 15565268
• Product Code: GXI
• UDI-Device Identifier: 00852454006301
• UDI-Public: (01)00852454006301(17)261205(10)35729589
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/27/2025

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 0045
• Device Catalogue Number: RLV 0045
• Device Lot Number: 35729589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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 Age: 35 YR
• Patient Sex: Female