BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACEPT

    MDR report key: 22890322 · Received August 25, 2025

    Report

    Report Number
    3006630150-2025-06873
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    June 25, 2025
    Report Date
    August 25, 2025
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006226
    PMA / PMN Number
    K222281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE INTERCEPT PROCEDURE, THE PHYSICIAN ENCOUNTERED VERY HARD BONE. WHILE MALLETING THE INTRODUCER CANNULA WITH THE DIAMOND STYLET, THE STYLET KEPT POPPING UP FROM THE INTRODUCER CANNULA AND ENDED UP BREAKING. THE STYLET WOULD NO LONGER CLICK INTO THE INTRODUCER CANNULA. THE SAME ISSUE ALSO OCCURRED WITH THE BEVEL STYLET. IT WAS NOTED THAT ONE OF THE T-HANDLES ON THE INTRODUCER CANNULA STARTED SPLITTING APART. A NEW KIT WAS OPENED AND A NEW DIAMOND STYLET AND BEVEL STYLET WERE USED TO COMPLETE THE PROCEDURE. THE INTRODUCER CANNULA, DIAMOND STYLET, AND TWO CURVED CANNULAS WERE RETURNED FOR ANALYSIS. A VISUAL INSPECTION REVEALED THAT ONE INTRODUCER CANNULA HANDLE WAS SLIGHTLY SPLIT BETWEEN THE DARK AND LIGHT GRAY PLASTIC AND THE SECOND INTRODUCER CANNULA HANDLE LATCH WAS BROKEN. IT WAS FOUND THAT THE DIAMOND STYLET LATCH WAS BROKEN AND TWO CURVED CANNULA TIPS WERE SHEARED. THE BEVEL STYLET WAS NOT RETURNED FOR ANALYSIS. IT COULD NOT BE CONFIRMED IF ANY DEVICE FRAGMENTS WERE LEFT BEHIND INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552634 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0055 36306158 00852454006226

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown