BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDELLA¿ PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 23108778 · Received September 22, 2025

    Report

    Report Number
    3024985933-2025-00028
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 29, 2025
    Report Date
    November 25, 2025
    Manufacturer
    ENDOTRONIX, INC
    Product Code
    MOM
    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, A2, A3, A4, B4, G3, G4, G6, H2, H4, H6, AND 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. FOLLOWING RECALIBRATION, THE MEAN PULMONARY ARTERY PRESSURE (MPAP) TREND HAS REMAINED STABLE AND CONSISTENT, INDICATING THAT THE INACCURACY WAS FINITE AND EFFECTIVELY CORRECTED. THE PATIENT HAS RETURNED TO OBTAINING ROUTINE READINGS AND NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE SUBMITTED VIA FOLLOW-UP REPORT WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE PATIENT'S DATA WAS REVIEWED BY ENDOTRONIX'S INTERNAL MONITORING PROGRAM AND SUSPECTED SENSOR INACCURACY WAS IDENTIFIED. THE SITE HAS BEEN INFORMED TO SCHEDULE A RECALIBRATION. THE PATIENT IS SCHEDULED TO UNDERGO A RIGHT HEART CATHETERIZATION (RHC) AND RECALIBRATION ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2535133 CARDELLA¿ PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC 100303-05 E230110

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male