BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDELLA¿ PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 22237715 · Received June 17, 2025

    Report

    Report Number
    3024985933-2025-00018
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    May 30, 2025
    Report Date
    November 18, 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 FIELDS WERE UPDATED/CORRECTED/ADDED: A2, A3, A4, B4, B5, G3, G6, H2, H3, H4, H6 AND H11. THE SUSPECTED SENSOR INACCURACY COULD NOT BE CONFIRMED AS THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND RHC/RECALIBRATION HAS NOT BEEN COMPLETED. 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. OUT OF AN ABUNDANCE OF CAUTION, THE TREATING PHYSICIAN HAS BEEN INFORMED OF THE POTENTIAL INACCURACY OF THE SENSOR READINGS AND INSTRUCTED NOT TO USE THE PULMONARY ARTERY (PA) MEASUREMENTS TO GUIDE TREATMENT DECISIONS. 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. BASED ON THE INFORMATION PROVIDED, 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED/CORRECTED/ADDED: B2, B3, B4, B5, D4, G3, G6, H2, H11 ADDITIONAL INFORMATION WILL BE SUBMITTED VIA FOLLOW-UP REPORT WITHIN 30 DAYS OF RECIEPT.

    Description of Event or Problem · 0

    AS OF (B)(6) 2025, THE PATIENT HAS NOT UNDERGONE RHC/RECALLIBRATION.

    Description of Event or Problem · 0

    ENDOTRONIX'S PROACTIVE MONITORING IDENTIFIED SUSPECTED SENSOR INACCURACY AND RECOMMENDED THE PATIENT UNDERGO RIGHT HEART CATHETERIZATION (RHC) TO VERIFY THE ACCURACY OF THE SENSOR. AS OF (B)(6) 2024, RECALIBRATION HAS NOT BEEN SCHEDULED.

    Description of Event or Problem · 0

    RECALIBRATION VIA RIGHT HEART CATHETERIZATION IS CURRENTLY PLANNED FOR (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448819 CARDELLA¿ PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC 100303-05 E211206

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other