BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDELLA¿ PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 23108774 · Received September 22, 2025

    Report

    Report Number
    3024985933-2025-00027
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    August 29, 2025
    Report Date
    December 9, 2025
    Manufacturer
    ENDOTRONIX, INC
    Product Code
    MOM
    PMA / PMN Number
    P230040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    APPROXIMATELY THIRTY MINUTES AFTER DEVICE IMPLANTATION THE PATIENT EXPERIENCED HEMOPTYSIS PROMPTING HOSPITALIZATION FOR FURTHER EVALUATION. THE PATIENT HAS SINCE RECOVERED AND HAS BEEN DISCHARGED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490514 CARDELLA¿ PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC 100303-05 E240102

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization