BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDELIA PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 25031510 · Received April 29, 2026

    Report

    Report Number
    3024985933-2026-00014
    Event Type
    Injury
    Date Received
    April 29, 2026
    Date of Event
    April 16, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ENDOTRONIX, INC
    Product Code
    MOM
    UDI-DI
    00850008997006
    PMA / PMN Number
    P230040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT ELECTED TO UNDERGO A SENSOR RECALIBRATION VIA RIGHT HEART CATHETERIZATION DUE TO SUSPECTED SENSOR INACCURACY. SUSPECTED SENSOR INACCURACY OR SENSOR DRIFT IS THE GRADUAL DEVIATION IN PRESSURE READINGS OVER TIME. IN THIS CASE, THE SENSOR WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THE DEVICE HISTORY RECORD (DHR) FOR THE SENSOR LOT WAS REVIEWED, AND IT WAS CONFIRMED THAT NO RELEVANT NONCONFORMANCES WERE ASSOCIATED WITH THE SENSOR LOT AT THE TIME OF MANUFACTURE. ON 2026-04-16 (1147 DAYS FROM IMPLANT), THE PATIENT UNDERWENT A RIGHT HEART CATHETERIZATION (RHC) RECALIBRATION. THE OFFSET DETERMINED DURING THE RECALIBRATION FELL INSIDE THE FLUID FILLED REFERENCE MEASUREMENT ERROR RANGE, THEREBY CONFIRMING THAT THE SENSOR WAS PERFORMING AS EXPECTED. AS A RESULT, THE REPORTED EVENT WAS NOT CONFIRMED. THE PRODUCTS INSTRUCTIONS FOR USE WERE REVIEWED AND NOTE THAT ENDOTRONIX MONITORS SENSOR PERFORMANCE OVER TIME. WHEN ANALYSIS SUGGESTS ANOMALOUS SENSOR PERFORMANCE, RECALIBRATION USING THE RHC PROCEDURE MAY BE REQUIRED. IF ANOMALOUS DATA IS CONFIRMED THROUGH THE INTERNAL MONITORING PROGRAM, ENDOTRONIX WILL NOTIFY THE SITE. THE INSTRUCTIONS FOR USE FURTHER STATE THAT WHEN ANOMALOUS READINGS ARE SUSPECTED, CORRECTIVE RECALIBRATION USING THE RHC PROCEDURE MAY BE NECESSARY. BASED ON THE REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO INDICATION OF A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE EVENT AND NO FURTHER CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, PER FEBRUARY DRIFT REVIEW MEETING HELD ON 20FEB2026, IHFM R&D IS RECOMMENDING THE SITE TO PAUSE USE OF PA DATA AND IS REQUESTING THE SITE TO SCHEDULE A RECALIBRATION. RECAL OCCURRED ON 16APR2026. A IHFM LEVEL OF AGREEMENTS REVIEW ON 20APR2026 FOUND THAT THERE WERE NO POST CAL FLAGS, THE PRESSURE ADJUSTMENT DECREASE BY 5.318 MMHG AND CONFIRMED SENSOR ACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091680 CORDELIA PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC 100303 E221031-01 00850008997006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other