BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUNWAY GUIDE CATHETER

    MDR report key: 1222847 · Received November 6, 2008

    Report

    Report Number
    2134265-2008-04250
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K033441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 99% STENOTIC LESION WAS LOCATED IN THE MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). VASCULAR ACCESS WAS GAINED THROUGH THE RADIAL ARTERY. THE PHYSICIAN INSERTED ANOTHER MANUFACTURER'S GUIDE WIRE THROUGH THE RUNWAY GUIDE CATHETER AND THE GUIDE WIRE EXITED THROUGH THE SIDE HOLES OF THE RUNWAY GUIDE CATHETER. SIGNIFICANT RESISTANCE WAS ENCOUNTERED UPON ATTEMPTING TO REMOVE THE GUIDE WIRE FROM THE RUNWAY GUIDE CATHETER'S SIDE HOLES. THE RUNWAY GUIDE CATHETER AND THE GUIDE WIRE WERE REMOVED TOGETHER WITHOUT INCIDENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PT INJURES OR COMPLICATIONS. THE PT'S STATUS WAS REPORTED AS "NO PROBLEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUNWAY GUIDE CATHETER DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC NA 11810532

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO'S RUNTHROUGH GUIDEWIRE