BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACEPT

    MDR report key: 23855904 · Received December 19, 2025

    Report

    Report Number
    3006630150-2025-11571
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    November 21, 2025
    Report Date
    March 25, 2026
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006301
    PMA / PMN Number
    K222281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND THE COMPLAINT AS REPORTED WAS NOT ABLE TO BE CONFIRMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF SHEARED PEEK - DISTAL TIP 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 REPORTED EVENT OF THE CURVED CANNULA SHEARED PEEK AT THE DISTAL TIP BEING LEFT BEHIND INSIDE THE PATIENT COULD NOT BE CONFIRMED. IT COULD NOT BE CONFIRMED WHETHER THE DEVICE FRAGMENT WAS CONTAINED INSIDE THE BONE OR OUTSIDE THE BONE. RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THEREFORE, THIS INVESTIGATION IS UNABLE TO DETERMINE A PROBABLE CAUSE FOR THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THERE WERE ISSUES WITH INSERTING THE PROBE INSIDE THE CURVED CANNULA. IT WAS NOTICED THAT THE CURVED CANNULA HAD A SHEARED PEEK AT THE DISTAL TIP. AN ADDITIONAL INTRACEPT KIT WAS OPENED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE CURVED CANNULA WAS FLUSHED OUT, BUT THE SHEARED PEAK DID NOT COME OUT. ONLY CLOTTED BLOOD CAME OUT, WHICH WAS NOTED AS NORMAL FOR THIS PROCEDURE. IT IS UNKNOWN IF THE SHEARED PEEK WAS STILL WITHIN THE BONE OR INSIDE THE PATIENT. THE SHEARED PEEK WAS NOT SEEN ON ANY IMAGING THAT WAS TAKEN DURING THE PROCEDURE. IN ADDITION, FOUR LEVELS WERE COMPLETED BEFORE THE ISSUE OCCURRED AND IT WAS NOTED THAT SOME HARD BONE WAS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THERE WERE ISSUES WITH INSERTING THE PROBE INSIDE THE CURVED CANNULA. IT WAS NOTICED THAT THE CURVED CANNULA HAD A SHEARED PEEK AT THE DISTAL TIP. AN ADDITIONAL INTRACEPT KIT WAS OPENED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE CURVED CANNULA WAS FLUSHED OUT, BUT THE SHEARED PEAK DID NOT COME OUT. ONLY CLOTTED BLOOD CAME OUT, WHICH WAS NOTED AS NORMAL FOR THIS PROCEDURE. IT IS UNKNOWN IF THE SHEARED PEEK WAS STILL WITHIN THE BONE OR INSIDE THE PATIENT. THE SHEARED PEEK WAS NOT SEEN ON ANY IMAGING THAT WAS TAKEN DURING THE PROCEDURE. IN ADDITION, FOUR LEVELS WERE COMPLETED BEFORE THE ISSUE OCCURRED AND IT WAS NOTED THAT SOME HARD BONE WAS ENCOUNTERED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3429 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0045 37434286 00852454006301

    Patients

    Seq Age Sex Outcome Treatment
    1