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

Model Number	RLV 0045
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a procedure and the physician noticed that the patient had hyper-sclerotic bone, which made it difficult to insert the instruments.The physician made attempts to insert the ablation tool and x-rays were continuously taken throughout the procedure.The physician noticed that a piece of the j-stylet had broken off inside the patient along with a portion of the guidewire cannula and the procedure was aborted.X-rays were taken to confirm the broken fragment was in the vertebral body and a computed tomography (ct) lumbar spine scan without contrast was ordered postop.No levels were treated.
Additional Manufacturer Narrative
A visual inspection of the returned j-stylet revealed that the shaft tip was broken.The reported event of the broken j-stylet was confirmed and the damaged instrument was likely due to use of excessive force during the procedure.
Event or Problem Description
It was reported that the patient underwent a procedure and the physician noticed that the patient had hyper-sclerotic bone, which made it difficult to insert the instruments.The physician made attempts to insert the ablation tool and x-rays were continuously taken throughout the procedure.The physician noticed that a piece of the j-stylet had broken off inside the patient along with a portion of the guidewire cannula and the procedure was aborted.X-rays were taken to confirm the broken fragment was in the vertebral body and a computed tomography (ct) lumbar spine scan without contrast was ordered postop.No levels were treated.

• 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: 21837299
• Report Number: 3006630150-2025-02477
• Device Sequence Number: 8642430
• Product Code: GXI
• UDI-Device Identifier: 00852454006301
• UDI-Public: 00852454006301
• 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): 07/08/2025

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 0045
• Device Catalogue Number: RLV 0045
• Device Lot Number: 35508066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown