BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDELIA PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 24952566 · Received April 22, 2026

    Report

    Report Number
    3024985933-2026-00013
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 30, 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 FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: B4, G3, G6, H2, H6, AND H11. H2: THE PATIENT ELECTED TO UNDERGO A SENSOR RECALIBRATION VIA RIGHT HEART CATHETERIZATION DUE TO PROACTIVE MONITORING OF 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 2026-04-02 (1674 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.

    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 20FEB2026, DURING THE FEBRUARY DRIFT REVIEW MEETING, EDWARDS IHFM RECOMMENDED THAT THE SITE PAUSE THE USE OF PA DATA AND RECOMMENDED THAT THE SITE PROCEED WITH SCHEDULING A RECALIBRATION. ON (B)(6) 2026 RHC/RECALIBRATION OCCURRED. IHFM R&D REVIEWED THE LEVEL OF AGREEMENT ON 10APR2026 AND FOUND NO POST CAL FLAGS, PRESSURE ADJUSTMENT INCREASE BY 9.041 MMHG AND CONFIRM SENSOR ACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211555 CORDELIA PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC 100303 E200902-02 00850008997006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other