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

Model Number	FG 0046
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	09/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician was advancing the curved cannula and upon extracting realized the tip had split in half.Physician attempted access again on the other vertebral body with a new curved cannula, which also split in half and this level was not able to be ablated.The physician was unable to extract the second split curved cannula the from the bone and ended up breaking the peek material off.The physician had to dissect down to remove as much of the material as possible.Patient is doing well.At 2 week follow up, the patient did not have any tenderness over the right side where the curved cannula was dissected.
Additional Manufacturer Narrative
The product was received and analyzed.The curved cannula assembly showed deformed peek material and missing peek material.
Event or Problem Description
Physician was advancing the curved cannula and upon extracting realized the tip had split in half.Physician attempted access again on the other vertebral body with a new curved cannula, which also split in half and this level was not able to be ablated.The physician was unable to extract the second split curved cannula the from the bone and ended up breaking the peek material off.The physician had to dissect down to remove as much of the material as possible.Patient is doing well.At 2 week follow up, the patient did not have any tenderness over the right side where the curved cannula was dissected.

• 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, INC.; 7201 metro blvd.; ste 300; edina MN 55439
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; suite 200; valencia, CA 91355-4068 ; 7632920920
• MDR Report Key: 18592361
• Report Number: 3006789852-2024-00003
• Device Sequence Number: 15101986
• Product Code: GXI
• UDI-Device Identifier: 00852454006035
• UDI-Public: 00852454006035
• 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: Health Professional
• 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: 04/21/2024
• Device Model Number: FG 0046
• Device Lot Number: 127411122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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: Male