MAUDE Adverse Event Report: RELIEVANT MEDSYSTEMS INTRACEPT ACCESS INSTRUMENTS; PROBE, RADIOFREQUENCY LESION AND ACCESSORIES

Model Number	RLV 0045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
J-stylet instrument broken off outside the vertebral body.Physician obtained an orthopedic consult and the surgeon was afraid the broken piece was too far anterior to retrieve safely.He was concerned about vascular damage trying to retrieve it.He suggested a ct scan and then a vascular surgery consult.
Additional Manufacturer Narrative
The j-stylet and curved cannula were received and analyzed.The distal end of the curved cannula was sheared, the distal end of the j stylet was broken off.
Event or Problem Description
J-stylet instrument broken off outside the vertebral body.Physician obtained an orthopedic consult and the surgeon was afraid the broken piece was too far anterior to retrieve safely.He was concerned about vascular damage trying to retrieve it.He suggested a ct scan and then a vascular surgery consult.Additional information was received from the physician.He reported that the patient had hardened bone, and that postoperatively the patient did well.The ct scan post-operatively showed that the broken piece of the j-stylet was in the adjacent to the venal caval complex.The patient had a 2nd ct scan with contrast which showed no signs of extravasation in the vena cava.The vascular surgeon who was consulted stated that it was a higher risk to remove the broken piece than to leave it in place and monitor it.The patient states at times he does feel like he feels something there.

• Brand Name: INTRACEPT ACCESS INSTRUMENTS
• Common Device Name: PROBE, RADIOFREQUENCY LESION AND ACCESSORIES
• Manufacturer (Section D): RELIEVANT MEDSYSTEMS; 1230 midas way; suite 200; sunnyvale CA 94085 4068
• Manufacturer (Section G): RELIEVANT MEDSYSTEMS; 1230 midas way; suite 200; sunnyvale CA 94085 4068
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; suite 200; valencia, CA 91355-4068 ; 7632920920
• MDR Report Key: 18451743
• Report Number: 3006789852-2024-00002
• Device Sequence Number: 20748416
• Product Code: GXI
• UDI-Device Identifier: 00852454006301
• UDI-Public: 00852454006301
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2025
• Device Model Number: RLV 0045
• Device Lot Number: 730053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• 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