BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 22290115 · Received June 19, 2025

    Report

    Report Number
    3024985933-2025-00015
    Event Type
    Death
    Date Received
    June 19, 2025
    Date of Event
    May 21, 2025
    Report Date
    October 28, 2025
    Manufacturer
    ENDOTRONIX, INC
    Product Code
    MOM
    UDI-DI
    00850008997006
    PMA / PMN Number
    P230040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED/ADDED: B4, G3, G6, H2, H3, H6 AND H11. (H3) THE DEVICE WAS NOT RECEIVED FOR ANALYSIS, NOR WAS AN AUTOPSY PROVIDED. REVIEW OF ALL AVAILABLE CLINICAL INFORMATION PRECLUDES DETERMINATION OF A DEFINITIVE CAUSE OF DEATH. THE PATIENT'S COMPLEX MEDICAL HISTORY, INCLUDING ADVANCED HEART FAILURE, SEVERE COPD, OBESITY, DIABETES, CKD, AND SUBSTANCE ABUSE, MAY HAVE INCREASED PROCEDURAL RISK CONTRIBUTING TO THE ADVERSE OUTCOME.ADDITIONALLY, A REVIEW OF ALL AVAILABLE PROCEDURAL INFORMATION RECEIVED FROM EDWARDS IHFM CLINICAL SPECIALISTS AND THE SITE (INTERNAL CASE REPORTS, MEETING MINUTES, AND THE SITE DEBRIEF MEETING) NOTED PROCEDURAL CHALLENGES THAT WERE EVIDENT, PARTICULARLY DURING WIRE PLACEMENT AND ADVANCEMENT AND REMOVAL OF THE FIRST DELIVERY SYSTEM. REVIEW OF ALL MANUFACTURER'S DEVICE HISTORY RECORDS (DHR) CONFIRMS THAT THE DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS. THE PRODUCT LABELING WARNS THAT ONLY TRAINED PERSONNEL SHOULD USE THE CORDELLA PULMONARY ARTERY SENSOR SYSTEM AND NOTES POTENTIAL RISKS ASSOCIATED WITH THE OVERALL PROCEDURE, INCLUDING BUT NOT LIMITED TO, HEMOPTYSIS AND VASCULAR/BLEEDING COMPLICATIONS. WHILE THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED, THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION OR DEFICIENCY CONTRIBUTED TO THE ADVERSE OUTCOME. THERE ARE CLINICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE PATIENT WAS SUCCESSFULLY IMPLANTED WITH CORDELLA PULMONARY ARTERY SENSOR. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. SEVERAL HOURS LATER, THE PATIENT CODED AND EXPIRED IN ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865630 CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC E240102-03 00850008997006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| D| R