BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CATHETER

    MDR report key: 2101264 · Received May 24, 2011

    Report

    Report Number
    2015691-2011-15602
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE HOSPITAL AND WILL NOT BE RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT RETURN OF THE PRODUCT, NOR COULD A ROOT CAUSE OR POTENTIAL CONTRIBUTING FACTORS BE IDENTIFIED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SWAN-GANZ CATHETER CAME APART AT THE 30 CENTIMETER MARK UPON REMOVAL FROM THE PATIENT. THE DISTAL PART OF THE CATHETER WAS OUT OF THE SHEATH AND WAS ABLE TO BE REMOVED WITHOUT NEGATIVE CONSEQUENCE TO THE PATIENT. FOLLOW UP INDICATED THAT AN ARROW SHEATH PERCUTANEOUS INTRODUCER WAS USED, THERE WAS NO RESISTANCE FELT WHEN PULLING THE INTRODUCER OUT, THE CATHETER WAS IN FOR 2 DAYS, IT IS UNKNOWN IF THE VASCULATURE WAS TORTOUS AND UNKNOWN IF THERE WAS PLACEMENT DIFFICULTIES. THE EXACT MODEL NUMBER WAS NOT REPORTED; HOWEVER, IT WAS INDICATED THAT IT WAS A SWAN-GANZ CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CATHETER DYG EDWARDS LIFESCIENCES, PR CCUNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1