BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRACEPT

    MDR report key: 23103242 · Received September 19, 2025

    Report

    Report Number
    3006630150-2025-07837
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    August 25, 2025
    Report Date
    October 31, 2025
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006226
    PMA / PMN Number
    K222281
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTRACEPT ACCESS INSTRUMENTS WERE RETURNED AND ANALYZED. A VISUAL INSPECTION REVEALED THAT ONE CURVED CANNULA HANDLE WAS BROKEN. ONE INTRODUCER CANNULA HANDLE WAS BROKEN BETWEEN THE DARK AND LIGHT GRAY PLASTIC HANDLE AND ITS SHAFT WAS SEVERELY BENT. THE SECOND INTRODUCER CANNULA SHAFT WAS BENT. THE SECOND CURVED CANNULA SCREW THREADS WERE CRACKED. THE BEVEL STYLET HANDLE WAS CRACKED. THE DIAMOND STYLET, THE STRAIGHT STYLET, AND THE THIRD CURVED CANNULA PASSED THE VISUAL INSPECTION. THE THIRD CURVED CANNULA WAS TESTED WITH A KNOWN GOOD J-STYLET AND A KNOWN GOOD INTRODUCER CANNULA. IT LACKED ANY EXTREME RESISTANCE AND LOCKED DURING THE FUNCTIONAL TEST. THE STRAIGHT STYLET WAS TESTED WITH A KNOWN GOOD CURVED CANNULA AND A KNOWN GOOD INTRODUCER CANNULA. IT LACKED ANY EXTREME RESISTANCE AND LOCKED DURING THE FUNCTIONAL TEST. THE DIAMOND STYLET WAS TESTED WITH A KNOWN GOOD INTRODUCER CANNULA AND IT LACKED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE HANDLE OF THE INTRODUCER CANNULA CRACKED APART AT THE SEAM AND THE TOOLS WERE UNABLE TO REACH THE ABLATION TARGET ZONE. IT WAS NOTED THAT THE PATIENT HAD VERY HARD BONE AND THE PHYSICIAN HAD TO MALLET MORE THAN USUAL DURING THE PROCEDURE. IN ADDITION, THERE WAS BENDING THAT WAS NOTED ON THE INTRACEPT ACCESS TOOLS. THE CURVED CANNULA ASSEMBLY WAS UNABLE TO REACH THE TARGET SAFELY AND THE PROCEDURE WAS ABORTED. NO HARM WAS CAUSED TO THE PATIENT AND THE CASE WILL BE RESCHEDULED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE HANDLE OF THE INTRODUCER CANNULA CRACKED APART AT THE SEAM AND THE TOOLS WERE UNABLE TO REACH THE ABLATION TARGET ZONE. IT WAS NOTED THAT THE PATIENT HAD VERY HARD BONE AND THE PHYSICIAN HAD TO MALLET MORE THAN USUAL DURING THE PROCEDURE. IN ADDITION, THERE WAS BENDING THAT WAS NOTED ON THE INTRACEPT ACCESS TOOLS. THE CURVED CANNULA ASSEMBLY WAS UNABLE TO REACH THE TARGET SAFELY AND THE PROCEDURE WAS ABORTED. NO HARM WAS CAUSED TO THE PATIENT AND THE CASE WILL BE RESCHEDULED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DISCHARGED WITH NO COMPLICATIONS. THE INTRACEPT INSTRUMENTS, DRILL, AND PROBE WERE ALL BENT IN AN ATTEMPT TO REACH THE TARGET ABLATION ZONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2843512 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0055 35831784 00852454006226

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention