BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 23658010 · Received November 26, 2025

    Report

    Report Number
    3024985933-2025-00040
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    October 29, 2025
    Report Date
    January 27, 2026
    Manufacturer
    ENDOTRONIX, INC
    Product Code
    MOM
    UDI-DI
    00850008997006
    PMA / PMN Number
    P230040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED/ADDED: B4, G3, G6, H2, H3, H6 AND H11. (H3) THE SENSOR (B)(6) WAS NOT RETURNED FOR EVALUATION SINCE IT REMAINS IMPLANTED WITHIN THE PATIENT. A REVIEW OF THE MANUFACTURING RECORDS FOR DELIVERY SYSTEM W/ SENSOR (B)(6) DID NOT REVEAL ANY ISSUES OR NONCONFORMANCES THAT COULD BE RELATED TO THE REPORTED EVENT. RIGHT HEART CATHETERIZATION IS A PROCEDURE THAT CARRIES INHERENT RISKS, INCLUDING BLEEDING AND VASCULAR COMPLICATIONS. AMONG THESE, HEMOTHORAX IS A RECOGNIZED AND POTENTIALLY SERIOUS ADVERSE EVENT, WHICH MAY OCCUR SECONDARY TO VASCULAR INJURY DURING PROCEDURAL MANIPULATION WITH INTERVENTIONAL PRODUCTS (SUCH AS GUIDEWIRES OR THE DELIVERY SYSTEM). IN THIS CASE, HANDLING AND PROCEDURAL FACTORS (DIFFICULTY GAINING NECK ACCESS, MULTIPLE GUIDEWIRES USED) MAY HAVE CONTRIBUTED TO THE EVENT. HEMOTHORAX IS A RECOGNIZED PROCEDURAL COMPLICATION AND IS ADDRESSED IN THE PRODUCT'S RISK DOCUMENTATION AND INSTRUCTIONS FOR USE. DESPITE THESE RISKS, THE CORDELLA PA SENSOR SYSTEM PROVIDES MEANINGFUL CLINICAL BENEFITS BY ENABLING REMOTE PULMONARY ARTERY PRESSURE MONITORING, SUPPORTING IMPROVED MANAGEMENT OF CHRONIC HEART FAILURE. THE DELIVERY SYSTEM USED IN THIS CASE WAS NOT RETURNED FOR ANALYSIS. PROCEDURAL FILM OR IMAGING WAS NOT AVAILABLE FOR REVIEW. CONSIDERING ALL INFORMATION AVAILABLE AT THIS TIME, KNOWN RIGHT HEART CATHETERIZATION RISKS OR HANDLING AND PROCEDURAL FACTORS (PROLONGED CASE TIME DUE TO FAILED RIJ ACCESS) MAY HAVE BEEN A CONTRIBUTING FACTOR TO THIS EVENT. THERE IS NO EVIDENCE TO SUGGEST A DESIGN OR MANUFACTURING ISSUE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS ONGOING. ADDITIONAL INFORMATION WILL BE SUBMITTED VIA FOLLOW-UP REPORT WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    POST-IMPLANT OF A CORDELLA SENSOR ON (B)(6) 2025, THE PATIENT EXPERIENCED A SUDDEN DROP IN BLOOD PRESSURE AS MANUAL COMPRESSION WAS HELD AT THE ACCESS SITE (JUGULAR ACCESS). A CT SCAN WAS PERFORMED TO RULE OUT COMPLICATIONS SUCH AS STROKE OR RETROPERITONEAL BLEEDING (RP), AND THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR MONITORING. BY (B)(6) 2025, REPORTS INDICATED THAT THE PATIENT HAD RETURNED TO BASELINE WITH NO SIGNS OF STROKE OR RETROPERITONEAL BLEED. THE PHYSICIAN LATER CONFIRMED THE PATIENT HAD BLED INTO THE PLEURAL SPACE DUE TO A CHALLENGING NECK ACCESS BUT WAS STABLE AND BREATHING ROOM AIR. THE PATIENT EXITED THE INTENSIVE CARE UNIT BY (B)(6) 2025 AND WAS DISCHARGED HOME BY (B)(6) 2025 WHEN POST-IMPLANT TRAINING WITH THE CORDELLA SYSTEM WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2569821 CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC E240102-03 00850008997006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| R