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

Model Number	FG0060
Medical Device Problem Codes	Component Missing (2306); Incomplete or Missing Packaging (2312)
Health Effect - Clinical Codes	Airway Obstruction (1699); Low Blood Pressure/ Hypotension (1914)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an intercept procedure the physician discovered that the instrument kit was missing a straight stylet.Another instrument kit was opened, where the straight stylet within the kit did not have a radio opaque marker.The patient experienced an airway and blood pressure issue during the procedure.The physician decided that due to the patient health issues and instrument issues to abort the procedure.

• Brand Name: INTRACEPT
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• 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; valencia, CA 91355 ; 7632920920
• MDR Report Key: 21367756
• Report Number: 3006789852-2025-00016
• Device Sequence Number: 12891365
• Product Code: GXI
• UDI-Device Identifier: 00852454006189
• UDI-Public: 00852454006189
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K170827
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2025

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 Expiration Date: 03/17/2025
• Device Model Number: FG0060
• Device Catalogue Number: FG0060
• Device Lot Number: 127307623
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2023
• 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: Other
• Patient Sex: Unknown