BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 22581708 · Received July 23, 2025

    Report

    Report Number
    3024985933-2025-00023
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    June 30, 2025
    Report Date
    November 20, 2025
    Manufacturer
    ENDOTRONIX, INC
    Product Code
    MOM
    UDI-DI
    00850008997006
    PMA / PMN Number
    P230040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: B4, G3, G6, H1, H2. H3, H4, H6 AND H11. (H3) RIGHT HEART CATHETERIZATION IS A PROCEDURE THAT CARRIES INHERENT RISKS, INCLUDING BLEEDING AND VASCULAR COMPLICATIONS. AMONG THESE, HEMOPTYSIS IS A KNOWN PROCEDURAL COMPLICATION AND IS NOTED IN THE PRODUCT'S RISK DOCUMENTS AND INSTRUCTIONS FOR USE AS A POTENTIAL RISK OF THE OVERALL PROCEDURE. HEMOPTYSIS IS TYPICALLY A TRANSIENT AND REVERSABLE ADVERSE EVENT, WHICH MAY OCCUR SECONDARY TO PATIENT FACTORS AND/OR INJURY TO THE ARTERIAL VESSEL WALL THROUGH HANDLING OF INTERVENTIONAL PRODUCTS USED DURING THE IMPLANT PROCEDURE (SUCH AS GUIDEWIRES OR THE DELIVERY SYSTEM). DESPITE THESE CONSIDERATIONS, THE CORDELLA SYSTEM PROVIDES MEANINGFUL CLINICAL BENEFITS THROUGH REMOTE PULMONARY ARTERY PRESSURE MONITORING, WHICH SUPPORTS MORE EFFECTIVE MANAGEMENT OF CHRONIC HEART FAILURE.THE PRODUCT USED IN THIS CASE WAS NOT RETURNED FOR ANALYSIS AND AS SUCH, A PRODUCT MALFUNCTION COULD NOT BE CONFIRMED. CONSIDERING ALL INFORMATION AVAILABLE AT THIS TIME, HANDLING AND PROCEDURAL FACTORS (MULTIPLE GUIDEWIRES USED AND DIFFICULTY GAINING WIRE ACCESS AT THE TARGET LOCATION DUE TO PATIENT ANATOMY) AND/OR PATIENT FACTORS (HYPERTENSION, VESSEL ANATOMY, LARGE RIGHT VENTRICLE, ANTI-PLATELET THERAPY) MAY HAVE BEEN CONTRIBUTING FACTORS TO THIS EVENT. THERE IS NO EVIDENCE TO SUGGEST A DESIGN OR MANUFACTURING CAUSE FOR THIS EVENT. AS SUCH, NO ADDITIONAL PREVENTATIVE OR CORRECTIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT DURING THE IMPLANT PROCEDURE, VESSEL ACCESS WAS INITIALLY ACHIEVED BUT WIRE ACCESS WAS LOST DURING ADVANCEMENT OF THE DS, REQUIRING MULTIPLE REWIRING ATTEMPTS UNTIL SUCCESSFUL DEPLOYMENT WAS COMPLETED USING A 0.014 GRAND SLAM WIRE. THE ACT WAS ELEVATED AT 305, ABOVE THE RECOMMENDED 200 PRIOR TO INSERTION. POST-PROCEDURE, THE PATIENT EXPERIENCED MINOR COUGHING AND SHORTNESS OF BREATH, WITH A SMALL AMOUNT OF BLEEDING OBSERVED VIA SUCTION. A CHEST X-RAY WAS PERFORMED, OXYGEN THERAPY INITIATED, AND PROTAMINE ADMINISTERED PER PHYSICIAN ORDERS BEFORE TRANSFER TO THE ICU FOR OBSERVATION. WITHIN 45-60 MINUTES, THE PATIENT STABILIZED WITH NORMAL VITAL SIGNS, WAS ALERT AND ORIENTED, AND REQUIRED NO FURTHER INTERVENTION. THE PATIENT WAS DISCHARGED LATER THAT DAY, AND BY (B)(6) 2025, A CLINICAL SPECIALIST CONFIRMED HE WAS HOME AND RECOVERING WELL.

    Description of Event or Problem · 0

    SHORTLY AFTER DEVICE IMPLANTATION, THE PATIENT EXPERIENCED COUGHING AND HEMOPTYSIS, ALONG WITH MILD SHORTNESS OF BREATH. THESE SYMPTOMS WERE ADDRESSED DURING HOSPITALIZATION, AND THE PATIENT HAS SINCE RECOVERED AND BEEN DISCHARGED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986127 CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC E240916-03 00850008997006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R