BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS LOCATOR 3D PLUS DELIVERY CATHETER

    MDR report key: 23821216 · Received December 16, 2025

    Report

    Report Number
    3015970743-2025-00006
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    October 30, 2025
    Report Date
    December 16, 2025
    Manufacturer
    CENTERPOINT SYSTEMS LLC
    Product Code
    DQY
    PMA / PMN Number
    K250828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF THE COMPLAINT INFORMATION, CENTERPOINT INQUIRED FOR ADDITIONAL INFORMATION AS THERE DID NOT APPEAR TO BE A DEVICE PROBLEM WHICH CONTRIBUTED TO THE SEPTUM PERFORATION DURING THIS EVENT. CENTERPOINT CONFIRMED FROM THE DISTRIBUTOR THAT THERE WAS NO ALLEGATION OF MALFUNCTION OF THE CPS LOCATOR 3D PLUS DELIVERY CATHETER. THE PATIENT REMAINED STABLE THROUGHOUT THE ENTIRE PROCEDURE, AND NO SERIOUS HEALTH CONSEQUENCES RESULTED FROM THIS EVENT. THE DOCUMENTATION INVESTIGATION DID NOT IDENTIFY ANY KNOWN NONCONFORMITIES. THE DEVICE WAS DISCARDED BY THE PHYSICIAN AND WAS NOT RETURNED FOR INVESTIGATION. A FINAL ROOT CAUSE COULD NOT BE DETERMINED. BASED ON RISK ANALYSIS AND INVESTIGATION RESULTS, NO FURTHER ACTION IS REQUIRED. NO PATIENT CONSEQUENCES OBSERVED AND THE PATIENT ANATOMY WAS NOTED AS VERY THIN WITH EASY PERFORATION INTO RIGHT VENTRICLE. CENTERPOINT IS REPORTING THIS EVENT OUT OF CAUTION TO COMPLY WITH APPLICABLE REGULATORY REQUIREMENTS.

    Description of Event or Problem · 0

    CARDIAC PERFORATION. DURING IMPLANT, SECOND ATTEMPT AT SUPERIOD MID SEPTUM USING LEAD 1, UNSUCCESSFUL IMPLANT DUE TO SEPTAL PERFORATION. THEN, AT FOURTH ATTEMPT, AT SUPERIOR BASAL SEPTUM USING LEAD 2, ALSO UNSUCCESSFUL IMPLANT DUE TO SEPTAL PERFORATION. VERY THIN WITH EASY PERFORATION INTO RV REPEATEDLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2444923 CPS LOCATOR 3D PLUS DELIVERY CATHETER PERCUTANEOUS CATHETER DQY CENTERPOINT SYSTEMS LLC DS4D400-42-IDE CL13946

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other