BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 23659367 · Received November 26, 2025

    Report

    Report Number
    3024985933-2025-00039
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    October 29, 2025
    Report Date
    May 28, 2026
    Manufacturer
    ENDOTRONIX, INC
    Product Code
    MOM
    UDI-DI
    00850008997006
    PMA / PMN Number
    P230040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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, DURING AN IMPLANT PROCEDURE, THE CORDELLA SENSOR WAS ADVANCED INTO THE DELIVERY SHEATH WHEN THE PHYSICIAN REPORTED FEELING AND HEARING A "POP" AS THE SENSOR TIP ENTERED THE HEMOSTASIS VALVE. THE MAJORITY OF THE SENSOR REMAINED OUTSIDE THE SHEATH AT THE TIME. THE DELIVERY SYSTEM WAS WITHDRAWN AND INSPECTED; NO VISIBLE DAMAGE WAS NOTED, AND INTERROGATION IN OPEN AIR CONFIRMED SIGNAL ACQUISITION WITHIN 3-4 SECONDS. THE SENSOR WAS REINSERTED AND DEPLOYED WITHOUT INCIDENT. POST-DEPLOYMENT CALIBRATION ATTEMPTS FAILED, WITH CONNECTION STRENGTH <50% AND SIGNIFICANT SIGNAL NOISE. MULTIPLE ANATOMICAL POSITIONS WERE TESTED USING TWO READERS, BUT A TRUE PULMONARY ARTERY WAVEFORM COULD NOT BE OBTAINED. THE PATIENT TOLERATED THE PROCEDURE WITHOUT COMPLICATIONS AND WAS DISCHARGED HOME IN STABLE CONDITION. ON (B)(6) 2025, A HOME VISIT WAS SCHEDULED FOR (B)(6) 2025 TO ATTEMPT CALIBRATION USING AN ALLOY READER. ON (B)(6) 2025, FIELD SERVICE ATTEMPTED CALIBRATION AT MULTIPLE ANATOMICAL SITES; NO USABLE SIGNAL WAS OBTAINED (MAX SS ~2700, NOISE 50-120 KHZ). ON (B)(6) 2025, THE VISIT WAS REPORTED UNSUCCESSFUL, AND ON (B)(6) 2025, FOLLOW-UP DISCUSSIONS OCCURRED REGARDING NEXT STEPS. ON (B)(6) 2025, THE PHYSICIAN INQUIRED ABOUT POSSIBLY RETRIEVING THE SENSOR AND IMPLANTING A SECOND SENSOR. ENDOTRONIX ADVISED AGAINST RETRIEVAL OR SECOND SENSOR PLACEMENT; HOWEVER, THE PHYSICIAN ELECTED TO PROCEED WITH CAUTION. ON (B)(6) 2025, AN EXPLANT ATTEMPT WAS MADE USING A 17F SHEATH AND SNARE TECHNIQUE. THE SENSOR FRACTURED DURING WITHDRAWAL; THE PROXIMAL ANCHOR AND A SMALL FRAGMENT WERE REMOVED, WHILE THE DISTAL ANCHOR AND MOST OF THE SENSOR REMAINED IN THE VESSEL. THE PHYSICIAN ASSESSED THAT THE DISTAL ANCHOR WAS PARTIALLY ENDOTHELIALIZED AND COULD NOT BE SAFELY REMOVED. THE PHYSICIAN PROCEEDED TO IMPLANT A SECOND SENSOR, CITING INTENT TO IMPROVE PATIENT QUALITY OF LIFE GIVEN AN ESTIMATED LIFE EXPECTANCY OF APPROXIMATELY TWO YEARS. THIS SAME DAY, A SECOND SENSOR WAS DEPLOYED SUCCESSFULLY. CALIBRATION ACHIEVED CONNECTION STRENGTH OF 89-93% WITH ACCEPTABLE NOISE LEVELS AND HIGH STATIC OFFSET. IMAGING CONFIRMED OPTIMAL POSITIONING OF THE SECOND SENSOR, WITH THE INITIAL SENSOR LOCATED DISTALLY. THE PATIENT WAS PLACED ON ANTICOAGULATION THERAPY AND OBSERVED OVERNIGHT. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY IN STABLE CONDITION. ON (B)(6) 2025, A HOME VISIT WAS COMPLETED; TRAINING AND PULMONARY ARTERY READINGS WERE SUCCESSFUL, AND THE PATIENT WAS REPORTED TO BE "DOING GREAT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3776 CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC E240102 00850008997006

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other