BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS LOCATOR 3D DELIVERY CATHETER

    MDR report key: 21139146 · Received January 13, 2025

    Report

    Report Number
    3015970743-2025-00001
    Event Type
    Injury
    Date Received
    January 13, 2025
    Date of Event
    November 25, 2024
    Report Date
    January 13, 2025
    Manufacturer
    CENTERPOINT SYSTEMS
    Product Code
    DQY
    PMA / PMN Number
    K230363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF THE COMPLAINT, CENTERPOINT SYSTEMS IMMEDIATELY REQUESTED ADDITIONAL INFORMATION IN ORDER TO DETERMINE WHAT FURTHER ACTION, IF ANY, IS REQUIRED AS WELL AS TO CLARIFY WHAT TOOK PLACE DURING THE EVENT. CENTERPOINT HAS NOT RECEIVED ANY ADDITIONAL INFORMATION INDICATING IF/HOW THE DEVICE WAS INVOLVED IN THE PERFORATION AND/OR HOW THE DEVICE MALFUNCTIONED . ALTHOUGH THERE IS NO INDICATION OF DEVICE MALFUNCTION OR THAT THE CPS LOCATOR 3D DELIVERY CATHETER WAS DIRECTLY INVOLVED IN THE PERFORATION, CENTERPOINT IS SUBMITTING THIS MEDICAL DEVICE ADVERSE EVENT REPORT OUT OF CAUTION TO ENSURE ALL REGULATORY REQUIREMENTS ARE MET. NO FURTHER INFORMATION OR CONCLUSIONS ARE AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    PERFORATION OCCURRED WHEN USING LOCATOR 3D. ULTIPACE LPA1231 & CPS LOCATOR 3D SHEATH PERFORATED SEPTUM INTO LV DURING LEFT BUNDLE AREA IMPLANT. NO PATIENT SYMPTOMS OR CONSEQUENCES. LEAD REPOSITIONED WITHOUT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567049 CPS LOCATOR 3D DELIVERY CATHETER PERCUTANEOUS CATHETER DQY CENTERPOINT SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown