BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 20181454 · Received September 10, 2024

    Report

    Report Number
    3024985933-2024-00008
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    July 26, 2024
    Report Date
    May 15, 2025
    Manufacturer
    ENDOTRONIX, INC
    Product Code
    MOM
    UDI-DI
    00850008997006
    PMA / PMN Number
    P230040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION G3: INITIAL REPORT DATE RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 0

    UPDATED SECTION(S): G6 AND H3: SECTION B5: ADDITIONAL INFORMATION RECEIVED INDICATES THAT A RIGHT HEART CATHETERIZATION (RHC) WAS PERFORMED TO CONFIRM THE ACCURACY OF THE PRESSURE SENSOR AGAINST A REFERENCE PRESSURE. THE SENSOR WAS RECALIBRATED, AND AN ADJUSTMENT WAS REQUIRED. SECTION B6: (B)(6) 2024 - CALIBRATION DURING RHC VIA SWAN-GANZ CONFIRMED THAT A SENSOR ADJUSTMENT OF 17.386MMHG WAS REQUIRED. ADDITIONAL INFORMATION WILL BE SUBMITTED VIA FOLLOW-UP REPORT WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    (H3) THE SENSOR WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. 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) 2024, THE PATIENT UNDERWENT A RIGHT HEART CATHETERIZATION (RHC) RECALIBRATION. THE OFFSET DETERMINED DURING THE RECALIBRATION FELL OUTSIDE THE FLUID-FILLED REFERENCE MEASUREMENT ERROR RANGE, THEREBY CONFIRMING THAT THE SENSOR WAS PROVIDING INACCURATE MEASUREMENTS. FOLLOWING RECALIBRATION, THE MPAP TREND HAS REMAINED STABLE AND CONSISTENT. WHILE THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED, THE MEASUREMENT STABILITY AFTERWARDS INDICATES THAT THE SENSOR'S INACCURATE MEASUREMENT WAS FINITE, AND HAS BEEN EFFECTIVELY CORRECTED THROUGH RECALIBRATION.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    SENSOR INACCURACY SUSPECTED. PATIENT WILL UNDERGO REGULARLY SCHEDULED RECALIBRATION ON 26-SEPT-2024 TO DETERMINE IF AN ADJUSTMENT IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221701 CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC 00850008997006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention