BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS LOCATOR 3D DELIVERY CATHETER

    MDR report key: 21462149 · Received February 25, 2025

    Report

    Report Number
    3015970743-2025-00003
    Event Type
    Injury
    Date Received
    February 25, 2025
    Date of Event
    January 29, 2025
    Report Date
    March 31, 2025
    Manufacturer
    CENTERPOINT SYSTEMS
    Product Code
    DQY
    UDI-DI
    00810024670123
    PMA / PMN Number
    K230363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VERY LITTLE INFORMATION WAS PROVIDED REGARDING THIS EVENT, EVEN AFTER REPEATED FOLLOW-UPS. CENTERPOINT COULD NOT DETERMINE ANY DEVICE MALFUNCTIONS AND COULD NOT DETERMINE THE HEALTH IMPACT TO THE PATIENT. BASED ON THE EVENT DESCRIPTION, CENTERPOINT IS REPORTING THIS INCIDENT OUT OF CAUTION TO ENSURE COMPLIANCE TO THE APPLICABLE REGULATORY REQUIREMENTS. THE DISTRIBUTOR HAS INDICATED THAT THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS A FOLLOW-UP TO THE REPORT 3015970743-2025-00003. CENTERPOINT RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. THE PATIENT HAD TO UNDERGO ADDITIONAL INTERVENTION DURING THE INITIAL PROCEDURE TO CORRECT THE PERFORATION THROUGH THE HEART. THE PATIENT WAS HOSPITALIZED FOLLOWING THE PROCEDURE. ON (B)(6) 2025, CENTERPOINT WAS INFORMED THAT THE PATIENT MADE A FULL RECOVERY.

    Description of Event or Problem · 0

    CPS LOCATOR SHEATH PERFORATION THROUGH THE RIGHT VENTRICLE APEX.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT REPORTED IN 3015970743-2025-00003. THE PATIENT REQUIRED INTERVENTION DURING THE SAME PROCEDURE TO REPAIR THE PERFORATION. THE PATIENT REMAINED IN THE HOSPITAL FOLLOWING THE PROCEDURE FOR A PROLONGED PERIOD TO MONITOR THE CONDITION. THE PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464348 CPS LOCATOR 3D DELIVERY CATHETER PERCUTANIOUS CATHETER DQY CENTERPOINT SYSTEMS DS2C200-42 CL13392 00810024670123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H