BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 20454319 · Received October 15, 2024

    Report

    Report Number
    3004936110-2024-01306
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    October 2, 2024
    Report Date
    October 15, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEMOPTYSIS DURING THE IMPLANT PROCEDURE, PRIOR TO CARDIOMEMS DELIVERY CATHETER INSERTION. AFTER RIGHT HEART CATHETERIZATION MEASUREMENTS WERE TAKEN A NON-ABBOTT GUIDEWIRE WAS INSERTED INTO THE PULMONARY WEDGE CATHETER AND ADVANCED INTO THE LEFT PULMONARY ARTERY. THE CATHETER WAS THEN EXCHANGED FOR A DIAGNOSTIC CATHETER AND THE GUIDEWIRE WAS REPLACED FOR ANOTHER NON-ABBOTT WIRE. THE WIRE AND DIAGNOSTIC CATHETER WERE ADVANCED INTO THE LEFT LOWER PULMONARY ARTERY FOR AN ANGIOGRAM. FOLLOWING THE ANGIOGRAM AND DURING REPOSITIONING OF THE CATHETER, THE PATIENT BEGAN TO COUGH. SOME HEMOPTYSIS WAS NOTED BY THE NURSE CAUSING A TEMPORARY HALT FOR EVALUATION PER THE PHYSICIAN. THE PATIENT REMAINED STABLE, AND THE HEMOPTYSIS RESOLVED WITHOUT INTERVENTION. THE PHYSICIAN DECIDED TO COMPLETE THE PROCEDURE. ANOTHER WIRE WAS PLACED AND THE CARDIOMEMS DELIVERY SYSTEM WAS PREPPED, ADVANCED, AND RELEASED. THE SENSOR WAS CALIBRATED, AND THE PATIENT WAS TRANSFERRED TO RECOVERY. A CHEST X-RAY WAS PERFORMED AND NOTED TO BE CLEAR. AS A PRECAUTION, THE PHYSICIAN EXTENDED THE PATIENT¿S RECOVERY TIME BY TWO HOURS FOR OBSERVATION BEFORE DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319804 HF SENSOR DELIVERY SYSTEM System, hemodynamic, implantable MOM ST. JUDE MEDICAL, INC. CM2000 10419119 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| R