BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDELLA PA SENSOR SYSTEM

    MDR report key: 19849857 · Received July 29, 2024

    Report

    Report Number
    3024985933-2024-00001
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    July 1, 2024
    Report Date
    October 16, 2024
    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
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTION(S): 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 ACCEPTABLE ERROR RANGE, THEREBY CONFIRMING THAT THE SENSOR WAS PROVIDING INACCURATE MEASUREMENTS. FOLLOWING RECALIBRATION, THE MPAP TREND HAS REMAINED STABLE AND CONSISTENT. THIS STABILITY INDICATES THAT THE SENSOR'S INACCURATE MEASUREMENT WAS FINITE AND HAS BEEN EFFECTIVELY CORRECTED THROUGH RECALIBRATION. WHILE THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED, IT IS POSSIBLE FOR THE CORDELLA SENSOR TO EXHIBIT A NEGATIVE SUSTAINED DECREASE IN MEASURED PRESSURE AS A RESULT OF ALTERNATE PHYSICAL, ELECTRICAL, AND OR PHYSIOLOGICAL MECHANISMS.

    Additional Manufacturer Narrative · 0

    NO DEVICE ANALYSIS RESULTS ARE AVAILABLE BECAUSE THE DEVICE REMAINS IMPLANTED, HOWEVER, THE ACTUAL DEVICE WAS EVALUATED VIA RHC. PER THE IFU, RHC IS REQUIRED TO RECALIBRATE THE SENSOR IF SENSOR INACCURACY IS SUSPECTED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    A RHC WAS PERFORMED TO RECALIBRATE THE PRESSURE SENSOR AGAINST A REFERENCE PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897261 CORDELLA PA SENSOR SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ENDOTRONIX, INC 00850008997006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention CORDELLA PA SENSOR READER