BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDELLA¿ PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 23108766 · Received September 22, 2025

    Report

    Report Number
    3024985933-2025-00034
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 29, 2025
    Report Date
    December 9, 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

    H11: THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: A2, A3, A4, B4, G3, G6, H2, H6, & H11. H2: EVALUATION SUMMARY: 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. THE SENSOR REMAINS IMPLANTED AND WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED ALL MANUFACTURING OPERATIONS MET SPECIFICATIONS WITH NO RELEVANT NONCONFORMANCE'S. THE SENSOR WAS FLAGGED FOR SUSPECTED DRIFT DURING PROACTIVE MONITORING, AND THE SITE WAS INSTRUCTED TO PAUSE USE OF PULMONARY ARTERY PRESSURE DATA. A RIGHT HEART CATHETERIZATION (RHC) RECALIBRATION WAS RECOMMENDED; HOWEVER, THE PATIENT HAS DECLINED TO PROCEED, AND RECALIBRATION HAS NOT BEEN SCHEDULED AS OF 30-OCT-2025. BASED ON AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED 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 CURRENTLY PENDING A RIGHT HEART CATHETERIZATION (RHC) AND SENSOR RECALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2535121 CARDELLA¿ PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC 100303-04

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female