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

Model Number	RLV 0055
Medical Device Problem Codes	Material Fragmentation (1261); Nonstandard Device (1420); Difficult to Remove (1528); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an intracept procedure, the j-stylet was difficult to remove after the channel was created with the curved cannula assembly.The sheath was removed to reposition the device, however, the sheath snapped off.It is unknown if any device fragments were left behind inside the patient.
Additional Manufacturer Narrative
The device was returned for evaluation and is pending a technical product analysis.
Event or Problem Description
It was reported that during an intracept procedure, the j-stylet was difficult to remove after the channel was created with the curved cannula assembly.The sheath was removed to reposition the device, however, the sheath snapped off.It is unknown if any device fragments were left behind inside the patient.Additional information was received that the device fragments were left inside the patient and they were contained inside the bone.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.
Additional Manufacturer Narrative
This report is report is being submitted to correct the event description field (b5) in section b, adverse event/product problem.The returned curved cannula was analyzed and a visual inspection revealed that the curved cannula shaft tip was broken.The curved cannula screw threads were also broken.The j-stylet was not returned for analysis.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.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, which is a known risk associated with the use of the intracept intraosseous nerve ablation system.
Event or Problem Description
It was reported that during an intracept procedure, the j-stylet was difficult to remove after the channel was created with the curved cannula assembly.The sheath was removed to reposition the device, however, the sheath snapped off.It is unknown if any device fragments were left behind inside the patient.Additional information was received that the device fragments were left inside the patient, and they were contained inside the bone.

• 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: 22302283
• Report Number: 3006630150-2025-04742
• Device Sequence Number: 15610449
• Product Code: GXI
• UDI-Device Identifier: 00852454006226
• UDI-Public: (01)00852454006226(17)261108(10)35582152
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup,Followup
• Report Date (Section B): 05/20/2026

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: 35582152
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 08/03/2025; 05/20/2026
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/18/2025; 08/28/2025; 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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 Sex: Male