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

Model Number	RLV 0055
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an intracept procedure where upon the physicians first few taps of the mallet, the j-stylet sharply dove inferiorly.Upon retracting the j-stylet and removal from the straight cannula, the physician noticed that a piece of the peek sheath had been sheared off and likely remained inside the patient.The procedure was aborted for further evaluation of the patient.The patient was then woken up after the procedure and experienced radicular pain.The patient was admitted to the hospital and had a magnetic resonance imaging (mri) and a computer tomography (ct) scan performed.The patients pain severity remained high.The physician believes that the curved cannula peek sheath is in the spinal canal.The physician reported that the neurosurgeon decompressed the nerve with a laminectomy.The physician visualized the breach, but did not find any sheared peek device fragments, only some bone fragments.The patient stated that they were experiencing less pain and that her hip pain improved.The patient also reported mostly having back pain.The patient was discharged from the hospital and their leg pain is gone, however, the patient continues to have low back pain.
Event or Problem Description
It was reported that the patient underwent an intracept procedure where upon the physicians first few taps of the mallet, the j-stylet sharply dove inferiorly.Upon retracting the j-stylet and removal from the straight cannula, the physician noticed that a piece of the peek sheath had been sheared off and likely remained inside the patient.The procedure was aborted for further evaluation of the patient.The patient was then woken up after the procedure and experienced radicular pain.The patient was admitted to the hospital and had a magnetic resonance imaging (mri) and a computer tomography (ct) scan performed.The patients pain severity remained high.The physician believes that the curved cannula peek sheath is in the spinal canal.The physician reported that the neurosurgeon decompressed the nerve with a laminectomy.The physician visualized the breach, but did not find any sheared peek device fragments, only some bone fragments.The patient stated that they were experiencing less pain and that her hip pain improved.The patient also reported mostly having back pain.The patient was discharged from the hospital and their leg pain is gone, however, the patient continues to have low back pain.
Additional Manufacturer Narrative
The curved cannula, j-stylet, bevel stylet, and introducer cannula were returned and analyzed.A visual inspection revealed that the curved cannula shaft tip was broken.The breakage of the tip was likely due to use of excessive force during the procedure.The j-stylet was tested with a known good curved cannula and a known good introducer cannula to confirm that it lacks any extreme resistance and locked during the functional test.The bevel stylet was tested with a known good introducer cannula to confirm that it lacks any extreme resistance and locked during the functional test.The introducer cannula was also tested with a known good bevel stylet to confirm that it lacks 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.

• 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: 23586226
• Report Number: 3006630150-2025-10536
• Device Sequence Number: 15779180
• Product Code: GXI
• UDI-Device Identifier: 00852454006226
• UDI-Public: (01)00852454006226(17)270311(10)36315014
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 01/09/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: RLV 0055
• Device Catalogue Number: RLV 0055
• Device Lot Number: 36315014
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• 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 Age: 56 YR
• Patient Sex: Female