BEUDAMED
    FDA Adverse Event Injury Summary report: N

    .018 ROADRUNNER GUIDEWIRE

    MDR report key: 20474540 · Received October 16, 2024

    Report

    Report Number
    MW5161176
    Event Type
    Injury
    Date Received
    October 16, 2024
    Date of Event
    October 2, 2024
    Report Date
    October 15, 2024
    Manufacturer
    COOK INCORPORATED
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    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 .018 COOK ROADRUNNER 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 (B)(6) 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. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270936 .018 ROADRUNNER GUIDEWIRE WIRE, GUIDE, CATHETER DQX COOK INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown