BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACEPT

    MDR report key: 22302283 · Received June 20, 2025

    Report

    Report Number
    3006630150-2025-04742
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    May 22, 2025
    Report Date
    May 20, 2026
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006226
    PMA / PMN Number
    K222281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION AND IS PENDING A TECHNICAL PRODUCT ANALYSIS.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315020 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0055 35582152 00852454006226

    Patients

    Seq Age Sex Outcome Treatment
    1