BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPS LOCATOR 3D DELIVERY CATHETER

    MDR report key: 19934541 · Received August 7, 2024

    Report

    Report Number
    3015970743-2024-00002
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    May 28, 2024
    Report Date
    August 7, 2024
    Manufacturer
    CENTERPOINT SYSTEMS LLC
    Product Code
    DQY
    PMA / PMN Number
    K230363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 INDICATION IF/HOW THE DEVICE WAS INVOVLED IN THE PERFORATION AND/OR HOW THE DEVICE MALFUNCITONED. 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 INFORMAITON OR CONCLUSIONS ARE AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    PERFORATION OCCURRED WHEN USING LOCATOR 3D. AFTER THE PLACEMENT OF THE MIDDLE SEPTUM OF THE RIGHT VENTRICULAR IN THE NEW IMPLANTATION, THE PATIENT COMPLAINED THAT HE DID NOT FEEL WELL, SO CONTINUOUS PRESSURE MEASUREMENT, FLUOROSCOPY, ECHO, ETC. WERE CONFIRMED. FLUROSCOPICALLY, CONSIDERING THE POSSIBILITY THAT THE PATIENT HAD MOVED FROM THE ATTENTION SEPTUM TO THE HINGE (ALTHOUGH THERE WAS NO PERICARDIAL EFFUSION ON THE ECHO), THE PATIENT'S CONDITION STABLIZED AFTER A THORACOTOMY TO STOP THE BLEEDING SITE. A SUBSITITUTE (EPICARDIAL LEAD) WAS USED AND THE PROCEDURE WAS TERMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396994 CPS LOCATOR 3D DELIVERY CATHETER PERCUTANEOUS CATHETER DQY CENTERPOINT SYSTEMS LLC DS2C200-42 CL12490

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown