BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDELLA PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 23199919 · Received October 2, 2025

    Report

    Report Number
    3024985-2025-00036
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    September 3, 2025
    Report Date
    November 25, 2025
    Manufacturer
    ENDOTRONIX, INC
    Product Code
    MOM
    PMA / PMN Number
    P230040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: A1, A2, A3, B4, D4, G6, H2, H4, H6, & H11. H2: THE CORDELLA IMPLANT IS DESIGNED FOR DEPLOYMENT WITHIN THE RIGHT PULMONARY ARTERY DISTAL TO THE APICAL BRANCH. THE IMPLANT BODY IS POSITIONED ON THE ANTERIOR WALL OF THE RIGHT PULMONARY ARTERY WITH THE DISTAL ANCHOR EXTENDING DOWN THE DOWNTURN OF THE VESSEL. THE DISTAL ANCHOR DESIGN ENSURES RESISTANCE TO PROXIMAL MOVEMENT OF THE IMPLANT AND ENSURES ROTATIONAL SELF-ALIGNMENT OF THE IMPLANT BODY WITH THE TARGET PLACEMENT POSITION OF THE READER ON THE PATIENT'S CHEST. THE PROXIMAL ANCHOR PROVIDES ADDITIONAL STABILITY AND APPOSITION OF THE IMPLANT BODY AGAINST THE VESSEL WALL. THE SENSOR WAS NOT RETURNED FOR EVALUATION AS IT REMAINED IMPLANTED IN THE PATIENT. 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. A REVIEW OF THE SENSOR IMAGES DURING AND DIRECTLY AFTER DEPLOYMENT CONFIRMED THAT THE IMPLANT POSITIONING AND ORIENTATION WERE OPTIMAL. THERE WERE NO NOTED ABNORMALITIES RELATED TO STRUCTURAL INTEGRITY OF THE SENSOR DURING OR AFTER DEPLOYMENT. HOWEVER, IMAGING OF THE SENSOR CONDUCTED DURING CALIBRATION REVEALED THAT IT HAD MOVED DISTAL TO THE TARGET ZONE AND HAD ROTATED TOWARDS THE COLLARBONE. THEREFORE, THE REPORTED EVENT WAS CONFIRMED. WHILE THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED, IT IS NOTED THAT IT IS POSSIBLE FOR THE SENSOR TO HAVE SLIGHTLY ROTATED SUPERIOR UPON DEPLOYMENT DUE TO PATIENT ANATOMY. THE PATIENT IS CURRENTLY ABLE TO TAKE READINGS FROM THE BACK USING AN ALLOY READER. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE IS NO INDICATION OF A DESIGN OR MANUFACTURING CAUSE FOR THE EVENT; THEREFORE, NO ADDITIONAL CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON (B)(6) 2025, A SENSOR WAS DEPLOYED IN THE ANTERIOR POSITION FOR A PATIENT. INITIAL CALIBRATION ATTEMPTS YIELDED A SIGNAL STRENGTH OF 85%, THOUGH INTERFERENCE REQUIRED MITIGATION. SUBSEQUENT ATTEMPTS FAILED TO REACH THE 80% THRESHOLD NECESSARY FOR LOCKING. AFTER APPROXIMATELY 10 MINUTES, THE PHYSICIAN PERFORMED FLUOROSCOPY, REVEALING THAT THE SENSOR HAD SHIFTED DISTALLY AND ROTATED TOWARD THE COLLARBONE. POST-OPERATIVELY, CALIBRATION ATTEMPTS FROM THE CHEST USING AN ALLOY READER WERE UNSUCCESSFUL DUE TO THE PATIENT'S BODY SIZE AND BREATHING PATTERN, WHICH CAUSED FLUCTUATING SIGNAL STRENGTH BELOW 80%. CALIBRATION WAS ULTIMATELY ACHIEVED FROM THE PATIENT'S BACK, WITH SEATED READINGS REACHING APPROXIMATELY 85%, THOUGH SIGNAL STRENGTH REMAINED UNSTABLE. THE PATIENT WAS DISCHARGED WITH THE ALLOY READER BUT WAS UNABLE TO PERFORM READINGS WITHOUT ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2458182 CORDELLA PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC 100303-05 E240102

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male