BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDELLA PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 24780960 · Received April 3, 2026

    Report

    Report Number
    3024985933-2026-00009
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 5, 2026
    Report Date
    April 3, 2026
    Manufacturer
    ENDOTRONIX, INC.
    Product Code
    MOM
    UDI-DI
    00850008997006
    PMA / PMN Number
    P230040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REMAINS ONGOING AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED IN A FOLLOW UP REPORT WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED ON (B)(6) 2026, THE PATIENT UNDERWENT RIGHT HEART CATHETERIZATION AND RECALIBRATION DUE TO THE SITE SUSPECTED INACCURACY IN SENSOR READINGS, AFTER WHICH EDWARDS IHFM PROVIDED A LEVELS OF AGREEMENT DETERMINATION ON (B)(6) 2026 AS PART OF POST PROCEDURAL EVALUATION. DURING THIS ASSESSMENT, NO POST CALIBRATION FLAGS WERE IDENTIFIED, AND A PRESSURE ADJUSTMENT OF NEGATIVE 10.0 MMHG WAS APPLIED; THE PREDICTED OFFSET WAS 20.6 MMHG WITH A DRIFT DELTA OF NEGATIVE 9.4, WHILE THE ACTUAL OFFSET AFTER RECALIBRATION MEASURED 40 MMHG, REFLECTING A CHANGE OPPOSITE THE PREDICTION THAT WAS CONSIDERED REASONABLE GIVEN THE HIGHLY VARIABLE DRIFT DELTA CAUSED BY FLUCTUATIONS IN THE PATIENTS VITALS AS NOTED IN THE TREND QUALITY REPORT. EDWARDS IHFM REVIEWED THE CAUTERIZATION LAB REPORT AND CONFIRMED THAT THE SYSTOLIC PEAK POINTS WERE CONSISTENT WITH THE REPORTED REFERENCE SYSTOLIC PEAK POINTS, WITH NO ISSUES IDENTIFIED IN THE CALIBRATION PROCESS. THE EVALUATION CONCLUDED THAT THE RESULTS WERE WITHIN FLUID FILLED LEVELS OF AGREEMENT, INDICATING ACCEPTABLE DEVICE PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839949 CORDELLA PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC. 100303 E220713-08 00850008997006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other