BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDELLA¿ PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 22792968 · Received August 13, 2025

    Report

    Report Number
    3024985933-2025-00025
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    July 2, 2025
    Report Date
    December 9, 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

    H11: THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: A2, A3, A4, B4, G3, G6, H2, H6, & H11. H2: EVALUATION SUMMARY: THE SENSOR WAS NOT RETURNED AS IT REMAINS IMPLANTED. ALL IMAGES AND IN-PROCESS MANUFACTURING INSPECTIONS AND TEST RESULTS WERE REVIEWED. THIS SENSOR PASSED ALL FUNCTIONAL AND VISUAL CHECKS, AND THERE WAS NO SIGN OF ANY ABNORMALITIES IN ITS WELD LINE INSPECTIONS, INTEGRITY INSPECTION, OR HERMITICITY RESULTS. ADDITIONALLY, THE SENSOR PASSED INTERROGATION AFTER STERILIZATION. THEREFORE, ALL BUILD/TESTING DOCUMENTATION SUPPORTS AND PROVIDES EVIDENCE THAT THIS SENSOR WAS CONFORMING TO ALL SPECIFICATIONS AND FUNCTIONING AS INTENDED PRIOR TO DISTRIBUTION. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. SENSOR FAILURE IS A KNOWN EVENT AND IS ADDRESSED IN THE PRODUCTS RISK DOCUMENTS WITH POTENTIAL CONTRIBUTING FACTORS INCLUDING, BUT NOT LIMITED TO, LARGE LINK-DISTANCE BETWEEN THE READER AND THE SENSOR. THE EVENT APPEARS TO BE ISOLATED IN NATURE AND ENDOTRONIX WILL CONTINUE TO TREND COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    FOLLOWING SUCCESSFUL IMPLANT OF THE SENSOR, THE READER WAS NOT ABLE TO DETECT A SIGNAL LOCK ON TO AND CALIBRATE THE SENSOR. AFTER MULTIPLE ATTEMPTS AND TROUBLESHOOTING, IT WAS DETERMINED THAT THE SENSOR HAD FAILED. DESPITE THESE ISSUES, THE PATIENT REMAINS CLINICALLY STABLE WITH NO CLINICAL CONSEQUENCES AND CONTINUES TO TAKE DAILY VITAL SIGN (BP, PULSE OXIMETRY AND WEIGHT) READINGS UTILIZING THE CORDELLA HEART FAILURE SYSTEM (CHFS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76633 CARDELLA¿ PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC E240102-03 00850008997006

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male