BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWAN-GANZ CCO/VIP

    MDR report key: 1010534 · Received March 5, 2008

    Report

    Report Number
    1010534
    Event Type
    Injury
    Date Received
    March 5, 2008
    Date of Event
    February 25, 2008
    Report Date
    March 4, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, LLC
    Product Code
    DYG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MD NOTES: ONE MD HAD PLACED A LEFT SUBCLAVIAN INTRODUCER. HE MADE SEVERAL ATTEMPTS AT PLACING A SWAN GANZ CATHETER THROUGH THE INTRODUCER AND WAS UNSUCCESSFUL. ANOTHER MD MADE SEVERAL ATTEMPTS. THE SWAN GANZ CATHETER WAS ADVANCED ON SEVERAL TRIES - KEPT POSITIONING IN THE RIGHT VENTRICLE AND WAS UNABLE TO GET IT TO MIGRATE INTO THE PULMONARY ARTERY. ATTEMPTED TO REMOVE THE CATHETER, IT WAS STUCK AT THE 40 CM. MARK. CHEST X-RAY SHOWED CATHETER LOOPED UP INTO THE LEFT INTERNAL JUGULAR VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CCO/VIP CATHETER, PA DYG EDWARDS LIFESCIENCES, LLC * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention DIALYSIS| DIALYSIS| NONE KNOWN| NONE KNOWN