BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORDIS CATHETER

    MDR report key: 1062569 · Received May 28, 2008

    Report

    Report Number
    MW5007351
    Event Type
    Other
    Date Received
    May 28, 2008
    Report Date
    May 28, 2008
    Manufacturer
    CORDIS CORP/PRODUCT QUALITY SYSTEMS
    Product Code
    DQO
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TODAY ON A ROUTINE PROCEDURE OF CARDIAC CATHETERIZATION, USING THE SAME TECHNIQUE USED OVER THE YEARS AND USING A CORDIS 6 FRENCH JL 4 DIAGNOSTIC CATHETER (CAT#534-620-T, LOT 13395954, EXPIRATION DATE 03/2011) OVER AN APPROPRIATE GUIDE WIRE, THE TIP OF THE CATHETER REACHED THE LEFT CORONARY OSTIUM, THE WIRE WAS REMOVED AND IMMEDIATELY THE DISTAL THREE INCHES OF THE CATHETER BROKE AWAY AND BEGAN FLOATING IN THE ARCH OF THE AORTA. INTRAVENOUS HEPARIN WAS ADMINISTERED AND DR. FROM INTERVENTIONAL RADIOLOGY WAS CALLED AND HE RETRIEVED THE FRAGMENT USING THE APPROPRIATE TECHNIQUE SAFELY. WE ARE NOTIFYING YOU OF THIS INCIDENT IN ORDER THAT YOU CAN DO ROOT CAUSE ANALYSIS TO PREVENT SUCH AN INCIDENT IN THE FUTURE. THE CATHETER WAS PICKED UP BY YOUR REPRESENTATIVE. [SEE SCANNED PAGES.]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS CATHETER CORDIS 6 FRENCH JL 4 DIAGNOSTIC CATHETER DQO CORDIS CORP/PRODUCT QUALITY SYSTEMS 13395954

    Patients

    Seq Age Sex Outcome Treatment
    1