BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDELLA PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 25254890 · Received May 22, 2026

    Report

    Report Number
    3024985933-2026-00018
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    May 11, 2026
    Report Date
    May 22, 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 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 (B)(6) 2026, 1,155 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 PRODUCT INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND NOTE THAT EDWARDS 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, EDWARDS WILL NOTIFY THE SITE. THE IFU FURTHER STATE THAT WHEN ANOMALOUS READINGS ARE SUSPECTED, CORRECTIVE RECALIBRATION USING THE RHC PROCEDURE MAY BE NECESSARY. BASED ON THE AVAILABLE INFORMATION NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    ON (B)(6) 2026, DURING A FEBRUARY DRIFT REVIEW, A CROSS-FUNCTIONAL TEAM RECOMMENDED PAUSING PULMONARY ARTERY DATA COLLECTION AND PERFORMING RECALIBRATION, AND CLINICAL DEVELOPMENT NOTIFIED THE SITE. ON 16-MAR-2026, A RIGHT HEART CATHETERIZATION WITH RECALIBRATION WAS SCHEDULED FOR (B)(6) 2026. ON 12-MAY-2026, CLINICAL DEVELOPMENT INSTRUCTED THE MYCORDELLA SUPPORT TEAM (MST) TO CONTACT THE PATIENT AND REQUEST SEATED AND SUPINE READINGS FOR SEVERAL DAYS. ON (B)(6) 2026, THE PATIENT WAS CONTACTED AND REPORTED FORGETTING TO TAKE READINGS THAT DAY BUT STATED THEY WOULD RESUME DAILY SEATED AND SUPINE READINGS AS INSTRUCTED. ON (B)(6) 2026, IMAGE REVIEW BY THE MEDICAL AFFAIRS TEAM CONFIRMED ANCHORS WERE ATTACHED AND THE SENSOR WAS LOCATED IN THE RIGHT PULMONARY ARTERY. ON 19-MAY-2026, RESEARCH AND DEVELOPMENT DRIFT REVIEW IDENTIFIED ONE NEGATIVE SUPINE READING ATTRIBUTED TO MOVEMENT AND MARKED "BAD DATA," WITH ALL SUBSEQUENT READINGS POSITIVE. ON (B)(6) 2026, ONE ADDITIONAL SUPINE READING SHOWED A -11.2 MMHG DIFFERENCE VERSUS REFERENCE MEAN PULMONARY ARTERY PRESSURE, A -1.214 MMHG ADJUSTMENT WAS APPLIED, AND NO CALIBRATION ISSUES WERE IDENTIFIED, CONFIRMING SENSOR ACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617765 CORDELLA PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC 100303 E230110-07 00850008997006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other