BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDELLA¿ PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 22888455 · Received August 25, 2025

    Report

    Report Number
    3024985933-2025-00026
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    May 6, 2025
    Report Date
    November 25, 2025
    Manufacturer
    ENDOTRONIX, INC
    Product Code
    MOM
    UDI-DI
    00850008997006
    PMA / PMN Number
    P230040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: A1, A2, A3, A4, B4, G3, G6, H2. H3, H6, & H11. H2: ALL PRESSURE TRANSDUCERS, REGARDLESS OF THE UNDERLYING TECHNOLOGY OR OPERATING PRINCIPLE, HAVE INHERENT BASELINE DRIFT OVER TIME. THE CORDELLA SENSOR IS A LONG-TERM IMPLANT DESIGNED TO HAVE LOW, CHARACTERIZED DRIFT. THE SENSOR IS CALIBRATED TO A "GOLD STANDARD" REFERENCE FLUID-FILLED MEASUREMENT ON THE DAY OF IMPLANTATION. IN CASES WHERE SENSOR INACCURACY IS SUSPECTED, PHYSICIANS CAN RELY ON ALTERNATIVE CLINICAL INDICATORS TO GUIDE CONTINUED PATIENT CARE. THE PATIENT MAY ELECT TO UNDERGO SENSOR RECALIBRATION VIA RIGHT HEART CATHETERIZATION AT A TIME DETERMINED COLLABORATIVELY WITH THE CARE TEAM. IN THIS CASE, THE SENSOR WAS NOT RETURNED FOR EVALUATION AS IT REMAINED IMPLANTED IN THE PATIENT. THE DEVICE HISTORY RECORD (DHR) FOR THE SENSOR LOT WAS REVIEWED AND IT WAS CONFIRMED THAT ALL MANUFACTURING OPERATIONS AND INSPECTIONS WERE PERFORMED, ALL ACCEPTANCE CRITERIA WERE MET, AND NO RELEVANT NONCONFORMANCES WERE ASSOCIATED WITH THE SENSOR LOT AT THE TIME OF MANUFACTURE. ON (B)(6) 2025, THE PATIENT UNDERWENT A SENSOR RECALIBRATION VIA RIGHT HEART CATHETERIZATION WHICH CONFIRMED THAT THE SENSOR OFFSET FELL OUTSIDE THE FLUID-FILLED REFERENCE MEASUREMENT ERROR RANGE, THEREBY CONFIRMING SENSOR DRIFT. WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, POSSIBLE CAUSES CAN BE ATTRIBUTED, BUT NOT LIMITED TO, PHYSICAL DAMAGE TO THE SENSOR, SENSOR RESPONSE TO THE PATIENT'S PHYSIOLOGY OR BODY'S INTERNAL ENVIRONMENT, OR AN IN VIVO DRIFT/SETTLING PROFILE THAT IS DIFFERENT FROM THE DRIFT CHARACTERIZATION AND CORRECTION DERIVED FROM MANUFACTURING DATA. SINCE RECALIBRATION, THE PATIENT HAS RETURNED TO OBTAINING ROUTINE READINGS AND NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE CLINIC CONTACTED THE MANUFACTURER INQUIRING ABOUT POTENTIAL DRIFT/INACCURACY OF THE MYCORDELLA SENSOR THAT HAD BEEN IMPLANTED IN THE PATIENT. AN ASSESSMENT AT THE TIME OF THE INITIAL REPORT NOTED NO EVIDENCE OF DRIFT AND THE CLINICAL SITE WAS INFORMED. ON (B)(6) 2025 DURING PROACTIVE MONITORING BY THE MANUFACTURER, POTENTIAL SENSOR DRIFT/INACCURACY WAS NOTED. THE CLINICAL SITE WAS INFORMED, AND RIGHT HEART CATHETERIZATION (RHC) WAS RECOMMENDED TO RECALIBRATE THE MYCORDELLA SENSOR. AS OF 15-AUG-2025, THE RHC HAD NOT BEEN COMPLETED. ADDITIONAL ATTEMPTS TO GATHER INFORMATION ARE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552864 CARDELLA¿ PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC E200615-07 00850008997006

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male