BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDELLA PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 19849858 · Received July 29, 2024

    Report

    Report Number
    3024985933-2024-00002
    Event Type
    Injury
    Date Received
    July 29, 2024
    Date of Event
    July 1, 2024
    Report Date
    May 14, 2025
    Manufacturer
    ENDOTRONIX, INC
    Product Code
    MOM
    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

    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 RECALIBRATION CONFIRMED THAT THE SENSOR ACCURACY FALLS WITHIN THE ACCEPTABLE BETWEEN THE CORDELLA SYSTEM AND FLUID-FILLED REFERENCE MEASUREMENT. BASED ON THE EVIDENCE, THE REPORTED COMPLAINT OF INACCURATE MEASUREMENT THERE WAS NO FAILURE DETECTED; THE SYSTEM WAS FOUND TO BE PERFORMING AS INTENDED AND WITHIN THE EXPECTED ACCURACY LIMITS.

    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. ADDIITONAL INFORMAITON WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

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

    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
    897262 CORDELLA PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention LOSARTAN| LVAD IMPLANT| TORSEMIDE 20MG/DAY