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

Model Number	RLV 0055
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an intracept procedure, the tip of the curved cannula peek broke off while it was being inserted into the patient.Hard bone was encountered and about one to two levels were completed prior to the issue occurring.The broken device fragment could not be found anywhere on the curved cannula and it was determined that the broken fragment was left inside the patient.It could not be confirmed whether the device fragment was contained inside the bone or outside the bone.The procedure was completed as scheduled.
Event or Problem Description
It was reported that during an intracept procedure, the tip of the curved cannula peek broke off while it was being inserted into the patient.Hard bone was encountered and about one to two levels were completed prior to the issue occurring.The broken device fragment could not be found anywhere on the curved cannula and it was determined that the broken fragment was left inside the patient.It could not be confirmed whether the device fragment was contained inside the bone or outside the bone.The procedure was completed as scheduled.
Additional Manufacturer Narrative
The curved cannula was returned and a visual inspection confirmed that the curved cannula shaft tip was broken.A labeling review did not reveal any anomalies as it states that with any surgical instrument, careful attention must be exercised to ensure that excessive force is not placed on the instruments or probe.Excessive force can result in product failure.It also states that breakage, slippage, misuse or mishandling of instruments or probe, such as on sharp edges, may cause burns or injury to the patient or operative personnel is a known risk associated with the use of the intracept intraosseous nerve ablation system.

• 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: 22155434
• Report Number: 3006630150-2025-03997
• Device Sequence Number: 20656087
• Product Code: GXI
• UDI-Device Identifier: 00852454006226
• UDI-Public: (01)00852454006226(17)270113(10)36334688
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 07/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 36334688
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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
• Patient Age: 67 YR
• Patient Sex: Female