BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS LOCATOR 3D DELIVERY CATHETER

    MDR report key: 21757795 · Received April 2, 2025

    Report

    Report Number
    3015970743-2025-00004
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    March 3, 2025
    Report Date
    April 2, 2025
    Manufacturer
    CENTERPOINT SYSTEMS LLC
    Product Code
    DQY
    PMA / PMN Number
    K230363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    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 THE PHYSICIAN INDICATED THAT THE SEPTUM OF THE PATIENT WAS VERY THIN, AND THE PERFORATION WAS CAUSED BY THE LEAD ONLY. DIAGNOSTIC IMAGING WAS PERFORMED TO CONFIRM THE PERFORATION, BUT IT WAS INCONCLUSIVE, THEREFORE THE SEPTUM PERFORATION WAS ASSUMED BY THE LEAD IMPEDENCE VALUES. THE PATIENT REMAINED STABLE THROUGHOUT THE ENTIRE PROCEDURE, AND NO SERIOUS HEALTH CONSEQUENCE RESULTED FROM THIS EVENT. ALTHOUGH IT WAS CLEAR FROM THE PHYSICIAN AND THE DISTRIBUTOR THAT THERE WAS NO FAULT IN THE CENTERPOINT PRODUCT (CPS LOCATOR 3D DELIVERY CATHETER), AND THE PERFORATION WAS RELATED TO THE LEAD ONLY AND DID NOT RESULT IN AN ADVERSE EVENT, CENTERPOINT IS REPORTING THIS EVENT OUT OF CAUTION TO COMPLY WITH APPLICABLE REGULATORY REQUIREMENTS.

    Description of Event or Problem · 0

    DURING CONDUCTION SYSTEM PACING PHYSICIAN WAS PLACING THE LEAD INTO THE LEFT BUNDLE BRANCH THROUGH CPS LOCATOR 3D CATHETER. DURING THE POSITIONING OF THE LEAD, IT WAS OBSERVED THAT THE LEAD IMPEDENCE WAS VERY HIGH AT POINT WHICH IS INDICATIVE OF PERFORATION. THEN THE LEAD WAS PULLED OUT WASHED THOROUGHLY AND AGAIN POSITITIONED. LIKE FIRST INSTANCE, AGAIN IT PERFORATED THE SEPTUM. PHYSICIAN THEN DECIDED TO PERFORM CONVENTIONAL DUAL CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371767 CPS LOCATOR 3D DELIVERY CATHETER PERCUATNEOUS CATHETER DQY CENTERPOINT SYSTEMS LLC DS2C200-42 CL12490

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown