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

Model Number	RLV 0055
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an intracept procedure, there was a slip of the introducer cannula prior to traversing the pedicle.The physician noticed that the introducer cannula jumped anteriorly quicker than usual and on the superior border of the pedicle.Bleeding was controlled throughout the procedure and dermabond was applied for closure.However, during the second procedure, the patient continued to experience bleeding and was transported to the emergency room (er).The physician stated that the cause of the bleeding was due to a vessel near or inside the pedicle being severed during the procedure.
Event or Problem Description
It was reported that during an intracept procedure, there was a slip of the introducer cannula prior to traversing the pedicle.The physician noticed that the introducer cannula jumped anteriorly quicker than usual and on the superior border of the pedicle.Bleeding was controlled throughout the procedure and dermabond was applied for closure.However, during the second procedure, the patient continued to experience bleeding and was transported to the emergency room (er).The physician stated that the cause of the bleeding was due to a vessel near or inside the pedicle being severed during the procedure.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the device was used per the instructions for use (ifu) product label.It states that breakage, slippage, misuse or mishandling of instruments or probe, such as on sharp edges, may cause burns or injury to the patient and unintended puncture wounds including vascular puncture and dural tear are adverse events potentially associated with the use of the intracept intraosseous nerve ablation system.A risk review was completed and confirmed that the event of hemorrhage major was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.With all the available information, boston scientific concludes that the lower gastric bleed is a known inherent risk with use of the device, as documented in the instructions for use (ifu).
Event or Problem Description
It was reported that during an intracept procedure, there was a slip of the introducer cannula prior to traversing the pedicle.The physician noticed that the introducer cannula jumped anteriorly quicker than usual and on the superior border of the pedicle.Bleeding was controlled throughout the procedure and dermabond was applied for closure.However, during the second procedure, the patient continued to experience bleeding and was transported to the emergency room (er).The physician stated that the cause of the bleeding was due to a vessel near or inside the pedicle being severed during the procedure.Additional information was received that the patient is doing well postoperatively.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the device was used per the instructions for use (ifu) product label.It states that breakage, slippage, misuse or mishandling of instruments or probe, such as on sharp edges, may cause burns or injury to the patient and unintended puncture wounds including vascular puncture and dural tear are adverse events potentially associated with the use of the intracept intraosseous nerve ablation system.A risk review was completed and confirmed that the event of blood loss was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.With all the available information, boston scientific concludes that the lower gastric bleed is a known inherent risk with use of the device, as documented in the instructions for use (ifu).

• 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: 23950203
• Report Number: 3006630150-2026-00021
• Device Sequence Number: 10757910
• Product Code: GXI
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 05/13/2026

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 Model Number: RLV 0055
• Device Catalogue Number: RLV 0055
• Device Lot Number: 37772123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 02/25/2026; 04/16/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 03/25/2026; 05/14/2026
• Date Device Manufactured: 08/11/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Race: Black Or African American