BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS LOCATOR 3D DELIVERY CATHETER

    MDR report key: 21454300 · Received February 24, 2025

    Report

    Report Number
    3015970743-2025-00002
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    January 23, 2025
    Report Date
    February 24, 2025
    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

    BASED ON THE INFORMATION PROVIDED BY THE PHYSICIAN AT THE TIME OF THE INCIDENT, THE CAUSE OF THIS EVENT IS RELATED TO THE ANATOMY OF THE PATIENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND BASED ON THE INVESTIGATION OF THE PRODUCTION RECORDS, AND THE INFORMATION PROVIDED BY THE PHYSICIAN AND DISTRIBUTOR, THERE WAS NO DEVICE PROBLEM WHICH OCCURRED DURING THE PROCEDURE. THE PATIENT WAS STABILIZED DUIRING THE PROCEDURE, AND THERE WAS NO PERMANENT HEALTH CONSEQUENCES FOLLOWING THE EVENT. CENTERPOINT SYSTEMS IS REPORTING THIS EVENT OUT OF CAUTION IN ORDER TO ENSURE COMPLIANCE TO THE APPLICABLE REGULATORY REQUIREMENTS.

    Description of Event or Problem · 0

    AFTER A PUNCTURE, THE PHYSICIAN INSERTED A 0.035INCH/150CM GUIDEWIRE UP TO PA AND CHECKED THE RV. AFTER THAT, SHE INSERTED A LOCATOR 3D ALONG THE WIRE. AFTER THE INSERTION, SHE REMOVED THE WIRE AND DILATOR, AND THEN MANIPULAED THE CATHETER TO DIRECT IT TO THE SEPTUM IN ORDER TO PERFORM CONTRAST. SINCE SHE WAS A LITTLE DISTRUSTFUL FOR LAO CONTRAST, SHE TRIED TO PERFORM CONTRAST IN RAO. WHEN PERFORMING IT, SHE CONFIRMED THAT THE CATHETER WAS COMING UP NEAR THE OUTFLOW TRACT, ADJUSTED THE POSITION AGAIN, AND TRIED TO PERFORM CHECKING BY SWINGING THE ARM TO THE LAO. AS A RESULT, SHE CONFIRMED THAT THE VITALS BECAME UNSTABLE AND TOOK EMERGENCY MEASURES. AT FIRST, THE PHYSICIAN'S OPINION WAS THAT SINCE SLIGHT CONVULSIONS WERE OBSERVED, SHE JUDGED THAT THE PATIENT HAD EPILEPSY AND ADMINISTERED MEDICINE. HOWEVER, IT DID NOT IMPROVE. AT THE SAME TIME, SHE CHECKED FOR PERICARDIAL EFFUSION USING ECHO, SHE COULD ONLY FIND THAT THERE MAY BE A SLIGHT AMOUNT OF IT. AT THIS TIME, SHE FIXED THE LOCATOR 3D USING TEGADERM TO PREVENT IT FROM MOVING. SINCE THE VITALS DID NOT IMPROVE AT ALL, SHE INSERTED A PIGTAIL CATHETER TO PERFORM CONTRAST AND PERFORATION WAS OBSERVED. SHE PERFORMED INSERTION AND INTUBATION OF PERICARDIAL DRAINAGE. WHEN SHE PERFORMED CT SCANS, SHE CONFIRMED PERICARDIAL EFFUSION AND AT THE SAME TIME, SHE COULD CONFIRM THAT THE LOCATOR 3D WAS DIRECTED TO THE SEPTUM. AFTER THAT, THE VITALS ALSO IMPROVED. SHE REMOVED THE LOCATOR 3D AND ATRIAL WIRE, PERFORMED CT SCANS AGAIN TO CONFIRM A DECREASE IN PERICARDIAL EFFUSION, AND THEN RETURN TO THE HCU. AFTER THAT, SHE TALKED WITH DR. KITA AND DR. ISHIZUKA, AND THEIR OPINIONS WERE THAT THERE WAS NO PROBLEM WITH THE PROCEDURE AND THAT IT WAS PROBABLY A HEART PROBLEM (THE HEART WAS FRAGILE) OF THE PATIENT. WHEN SHE CHECKED THE LAO CONTRAST, THE CONTRAST AGENT WAS ALSO FOUND NEAR THE EPICARDIUM. THEREFORE, THE POSSIBILITY OF MOVEMENT OF THE LOCATOR 3D DURING THE VIEW CHANGE, WHICH WAS THE ONLY POSSIBLE CAUSE FOR THE OCCURRENCE OF THE ISSUE, DISAPPEARED, LEADING TO THE ABOVE OPINION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544001 CPS LOCATOR 3D DELIVERY CATHETER PERCUTANEOUS CATHETER DQY CENTERPOINT SYSTEMS LLC DS2C200-42 CL13039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention