BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS LOCATOR 3D PLUS DELIVERY CATHETER

    MDR report key: 24185253 · Received January 26, 2026

    Report

    Report Number
    3015970743-2026-00008
    Event Type
    Injury
    Date Received
    January 26, 2026
    Date of Event
    November 18, 2025
    Report Date
    January 26, 2026
    Manufacturer
    CENTERPOINT SYSTEMS LLC
    Product Code
    DQY
    PMA / PMN Number
    K250828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 ABOUT THE EVENT SINCE NO PATIENT CONSEQUENCES WERE NOTED BY THE PHYSICIAN, BUT THE ADVERSE EVENT CODES FOR SERIOUS INJURY AND ARRYTHMIA WERE SELECTED. CENTERPOINT CONFIRMED FROM THE DISTRIBUTOR THAT NO PERMANENT INJURY OCCURRED AND THE ADVERSE EVENT WAS NOTED TO BE POSSIBLY RELATED TO CPS LOCATOR 3D PLUS. AFTER TEMPORARILY PACING THE PATIENT, THE LEAD IMPLANTATION RESUMED AND WAS SUCCESSFULLY COMPLETED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND NO SERIOUS HEALTH CONSEQUENCE RESULTED FROM THIS EVENT. IN THE EVENT THAT A PATIENT HAS A DISEASED CONDUCTION SYSTEM--PRESUMABLY WHY THEY ARE GETTING A PACEMAKER IN THE FIRST PLACE--IT IS POSSIBLE TO INDUCE COMPLETE CONDUCTION SYSTEM BLOCK BY WAY OF MINOR MANIPULATION OF A CATHETER IN THE HEART. IT IS NOT NECESSARILY DUE TO ANY PARTICULAR DEFICIENCY OF THE CATHETER AND MAY BE CONSIDERED A GENERAL PROCEDURAL COMPLICATION. THE DEVICE WAS NOT RETURNED FOR FURTHER EVALUATION; THEREFORE, IT COULD NOT BE DEFINITIVELY REFUTED THAT THE EVENT WAS NOT CAUSED BY A MALFUNCTION OR MISUSE OF THE DEVICE. CENTERPOINT IS REPORTING THIS EVENT OUT OF CAUTION TO COMPLY WITH APPLICABLE REGULATORY REQUIREMENTS.

    Description of Event or Problem · 0

    DURING IMPLANT PROCEDURE, SUBJECTS CONDUCTION SYSTEM WAS DISRUPTED FROM DELIVERY CATHETER PLACEMENT AT INTRAVENTRICULAR SEPTUM, CAUSING SUBJECT TO DEVELOP VENTRICULAR STANDSTILL. TRANSCUTANEOUS PACING: IMMEDIATELY ADMINISTERED, AND RIGHT ATRIAL LEAD TEMPORARILY DEPLOYED TO RIGHT VENTRICLE FOR PACING SUPPORT. CSP-ICD LEAD IMPLANTATION RESUMED, AND NO COMPLICATIONS RESULTED FROM STANDSTILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244972 CPS LOCATOR 3D PLUS DELIVERY CATHETER PERCUTANEOUS CATHETER DQY CENTERPOINT SYSTEMS LLC DS4D300-45 CL14207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention