BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 20181457 · Received September 10, 2024

    Report

    Report Number
    3024985933-2024-00006
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    August 14, 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
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE SENSOR WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THE PATIENT UNDERWENT RECALIBRATION 1 YEAR AND 8 MONTHS AFTER IMPLANT, WHICH CONFIRMED THAT THE SENSOR WAS PERFORMING AS INTENDED AND WITHIN EXPECTED ACCURACY LIMITS, E.G. WITHIN THE PREDICTED 3-YEAR LIMITS OF AGREEMENT BETWEEN THE CORDELLA SYSTEM AND FLUID-FILLED REFERENCE MEASUREMENT. AS A RESULT, THE REPORTED INACCURATE MEASUREMENT ALLEGATION WAS NOT CONFIRMED.

    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. IT WAS NOTED THAT THE SENSOR CALIBRATION WAS WITHIN THE FLUID FILLED LIMITS OF AGREEMENT; THEREFORE, NO ADJUSTMENT WAS REQUIRED. HOWEVER, AN OFFSET ADJUSTMENT OF 1.8 MMHG WAS CONDUCTED TO FINE TUNE THE SENSOR ACCURACY AS PART OF THE RECAL. ADDITIONAL INFORMATION WILL BE SUBMITTED VIA FOLLOW-UP REPORT WITHIN 30 DAYS OF RECEIPT.

    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 SITE REPORTED SUSPECTED SENSOR INACCURACY. THE PATIENT WILL NEED RECALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221704 CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC 00850008997006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention