BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACEPT

    MDR report key: 22146967 · Received June 4, 2025

    Report

    Report Number
    3006630150-2025-03968
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    May 6, 2025
    Report Date
    October 23, 2025
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006301
    PMA / PMN Number
    K222281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS REPORT IS BEING SUBMITTED TO CORRECT THE IMPACT CODE DESCRIPTION, IMPACT CODE FIELD (H6) IN SECTION H, DEVICE MANUFACTURERS ONLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DURING THE INTRACEPT PROCEDURE, THE PHYSICIAN ENCOUNTERED HARD BONE. WHEN THE PHYSICIAN REMOVED THE CURVED CANNULA, HE NOTICED THAT THE TIP WAS BROKEN. THE BROKEN DEVICE FRAGMENT WAS UNABLE TO BE RETRIEVED DURING THE PROCEDURE, AND IT COULD NOT BE CONFIRMED THAT THE DEVICE FRAGMENT WAS CONTAINED INSIDE THE BONE VIA FLUOROSCOPY. AN ADDITIONAL KIT WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED AIR EMBOLISM DURING THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DURING THE INTRACEPT PROCEDURE, THE PHYSICIAN ENCOUNTERED HARD BONE. WHEN THE PHYSICIAN REMOVED THE CURVED CANNULA, HE NOTICED THAT THE TIP WAS BROKEN. THE BROKEN DEVICE FRAGMENT WAS UNABLE TO BE RETRIEVED DURING THE PROCEDURE, AND IT COULD NOT BE CONFIRMED THAT THE DEVICE FRAGMENT WAS CONTAINED INSIDE THE BONE VIA FLUOROSCOPY. AN ADDITIONAL KIT WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED AIR EMBOLISM DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS INCLUDING AIR EMBOLISM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DURING THE INTERCEPT PROCEDURE, THE PHYSICIAN ENCOUNTERED HARD BONE. WHEN THE PHYSICIAN REMOVED THE CURVED CANNULA, HE NOTICED THAT THE TIP WAS BROKEN. THE BROKEN DEVICE FRAGMENT WAS UNABLE TO BE RETRIEVED DURING THE PROCEDURE, AND IT COULD NOT BE CONFIRMED THAT THE DEVICE FRAGMENT WAS CONTAINED INSIDE THE BONE VIA FLUOROSCOPY. AN ADDITIONAL KIT WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED AIR EMBOLISM DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS INCLUDING AIR EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937688 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0045 35788378 00852454006301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male