BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 22581705 · Received July 23, 2025

    Report

    Report Number
    3024985933-2025-00022
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    June 27, 2025
    Report Date
    December 17, 2025
    Manufacturer
    ENDOTRONIX, INC
    Product Code
    MOM
    UDI-DI
    00850008997006
    PMA / PMN Number
    P230040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED/ADDED: B4, G3, G6, H2, H3, H6 AND H11. (H3) 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. THE PRODUCT'S INSTRUCTIONS FOR USE WERE REVIEWED AND WARNS THE USER THAT, "TO ENSURE ACCURACY, THE SENSOR MUST BE CALIBRATED APPROXIMATELY EVERY THREE YEARS USING A RIGHT HEART CATHETERIZATION PROCEDURE." BASED ON THE INFORMATION PROVIDED, NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. REFERENCE ALSO 3024985933-2024-00012.

    Description of Event or Problem · 0

    THE SITE SUSPECTED SENSOR INACCURACY AND THE PATIENT WAS REVIEWED BY ENDOTRONIX'S INTERNAL MONITORING WHERE IT WAS DETERMINED THAT THIS PATIENT IS SUSPECTED FOR SENSOR INACCURACY. THE CLINICAL SPECIALIST (CS) EMAILED THE SITE COORDINATOR LETTING THEM KNOW TO STOP TREATING BASED ON MPAP. THE PATIENT WILL BE SCHEDULED FOR RECALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985973 CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC E211206-08 00850008997006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female