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

Model Number	RLV 0055
Medical Device Problem Codes	Defective Device (2588); Difficult to Advance (2920); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an intracept procedure, the handle of the introducer cannula cracked apart at the seam and the tools were unable to reach the ablation target zone.It was noted that the patient had very hard bone and the physician had to mallet more than usual during the procedure.In addition, there was bending that was noted on the intracept access tools.The curved cannula assembly was unable to reach the target safely and the procedure was aborted.No harm was caused to the patient and the case will be rescheduled.
Additional Manufacturer Narrative
The intracept access instruments were returned and analyzed.A visual inspection revealed that one curved cannula handle was broken.One introducer cannula handle was broken between the dark and light gray plastic handle and its shaft was severely bent.The second introducer cannula shaft was bent.The second curved cannula screw threads were cracked.The bevel stylet handle was cracked.The diamond stylet, the straight stylet, and the third curved cannula passed the visual inspection.The third curved cannula was tested with a known good j-stylet and a known good introducer cannula.It lacked any extreme resistance and locked during the functional test.The straight stylet was tested with a known good curved cannula and a known good introducer cannula.It lacked any extreme resistance and locked during the functional test.The diamond stylet was tested with a known good introducer cannula and it lacked any extreme resistance and locked during the functional test.A labeling review did not reveal any anomalies as it states that as with any surgical instrument, careful attention must be exercised to ensure that excessive force is not placed on the instruments or probe.
Event or Problem Description
It was reported that during an intracept procedure, the handle of the introducer cannula cracked apart at the seam and the tools were unable to reach the ablation target zone.It was noted that the patient had very hard bone and the physician had to mallet more than usual during the procedure.In addition, there was bending that was noted on the intracept access tools.The curved cannula assembly was unable to reach the target safely and the procedure was aborted.No harm was caused to the patient and the case will be rescheduled.Additional information was received that the patient was discharged with no complications.The intracept instruments, drill, and probe were all bent in an attempt to reach the target ablation zone.

• Brand Name: INTRACEPT
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): RELIEVANT MEDSYSTEMS, INC.; 1230 midas way suite 200; sunnyvale CA 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: 23103242
• Report Number: 3006630150-2025-07837
• Device Sequence Number: 9702515
• Product Code: GXI
• UDI-Device Identifier: 00852454006226
• UDI-Public: (01)00852454006226(17)270109(10)35831784
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 10/31/2025

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 0055
• Device Catalogue Number: RLV 0055
• Device Lot Number: 35831784
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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 Age: 64 YR
• Patient Sex: Female