BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDELIA¿ PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 21769467 · Received April 3, 2025

    Report

    Report Number
    3024985933-2025-00009
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 12, 2025
    Report Date
    June 19, 2025
    Manufacturer
    ENDOTRONIX, INC
    Product Code
    MOM
    UDI-DI
    00850008997006
    PMA / PMN Number
    P230040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS : B1 (FROM AE TO PP), G3, H1 (FROM SI TO MALFUNCTION), H2 (CORRECTION) AND H11. THIS MDR WAS SUBMITTED IN ERROR. UPON REVIEW IT WAS NOTED THAT THIS EVENT DOES NOT MEET THE CRITERIA FOR REPORTING AS AND MDR REPORTABLE EVENT PER 21 CFR, PART 803. THE PATIENT DID NOT REQUIRE ADDITIONAL UNPLANNED DIAGNOSTIC OR THERAPEUTIC PROCEDURES, OR MEDICAL OR SURGICAL INTERVENTION AS 3-YEAR PLANNED RECALIBRATIONS ARE PART OF THE IFU AND INTENDED USE OF THE DEVICE. NO ADDITIONAL, UNPLANNED RISK WAS INTRODUCED. IN THIS SPECIFIC CASE, IT WAS REPORTED THAT SENSOR INACCURACY WAS NOTED DURING A ROUTINE, SCHEDULED 3-YEAR RHC/RECALIBRATION. THE INACCURATE READINGS DID NOT RESULT IN SERIOUS INJURY OR DEATH AND NO INCORRECT THERAPEUTIC ACTION WAS TAKEN BASED ON THE DATA. ALTERNATE MEANS OF ASSESSING THE PATIENTS' OVERALL CONDITION WERE AVAILABLE AND USED EFFECTIVELY, SPECIFICALLY, PERIPHERAL BLOOD PRESSURE, HEART RATE, PULSE OXIMETRY AND WEIGHT WERE MONITORED VIA THE CORDELLA HEART FAILURE SYSTEM (CHFS). THE CLINICIAN WAS ABLE TO IDENTIFY THE INACCURACY DURING THE REGULARLY SCHEDULED 3-YEAR RECALIBRATION (PLANNED PROCEDURE). THE PATIENT DID NOT REQUIRE ADDITIONAL UNPLANNED DIAGNOSTIC OR THERAPEUTIC PROCEDURES, OR MEDICAL OR SURGICAL INTERVENTION AS 3-YEAR PLANNED RECALIBRATIONS ARE PART OF THE IFU AND INTENDED USE OF THE DEVICE. NO ADDITIONAL, UNPLANNED RISK WAS INTRODUCED. SENSOR DRIFT IS A RECOGNIZED AND WELL-CHARACTERIZED PHENOMENON INHERENT TO THE OPERATION OF IMPLANTABLE PRESSURE TRANSDUCER TECHNOLOGIES. THE CORDELLA PULMONARY ARTERY SENSOR PERFORMANCE OVER TIME MAY EXHIBIT GRADUAL SIGNAL DRIFT DUE TO VARIOUS PHYSICAL AND ENVIRONMENTAL FACTORS INCLUDING MATERIAL FATIGUE AND LONG-TERM EXPOSURE TO PHYSIOLOGICAL CONDITIONS. THIS TYPE OF SENSOR DRIFT DOES NOT INDICATE A DEVICE MALFUNCTION OR FAILURE MODE AS IT IS A KNOWN AND ANTICIPATED ASPECT OF THE DEVICE'S OPERATIONAL LIFE. CLINICAL INTERPRETATION STRATEGIES ARE INTEGRATED INTO THE OVERALL SYSTEM DESIGN. THE PERFORMANCE CHARACTERISTICS AND POTENTIAL FOR SENSOR DRIFT HAVE BEEN EVALUATED DURING DESIGN VERIFICATION AND VALIDATION, AND ARE FACTORED INTO CLINICAL MANAGEMENT PROTOCOLS. AS PER THE DEVICE APPROVAL AND INSTRUCTIONS FOR USE, PATIENTS ARE REQUIRED TO UNDERGO RIGHT HEART CATHETERIZATION EVERY THREE (3) YEARS TO VERIFY THE ACCURACY OF THE SENSOR AGAINST A FLUID-FILLED REFERENCE.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: D4, G3, G6, H2, H4 AND H6. H11: 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) 2025 (1476 DAYS FROM IMPLANT), THE PATIENT UNDERWENT A 3-YEAR 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.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT ROUTINE 3-YEAR RHC TO CHECK THE ACCURACY OF THE SENSOR. THE PATIENT WAS ALSO UPGRADED TO THE NEXT GENERATION READER. FOLLOWING THE RECALIBRATION, R&D REVIEWED THE READINGS TAKEN WITH BOTH READERS, AND IT WAS DETERMINED THAT THE RESULTS WERE OUTSIDE RANGE OF ACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847417 CORDELIA¿ PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC E200902-02 00850008997006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown