BEUDAMED
    FDA Adverse Event Summary report: N

    TRAILBLAZER

    MDR report key: 1883396 · Received October 1, 2010

    Report

    Report Number
    1883396
    Date Received
    October 1, 2010
    Date of Event
    August 30, 2010
    Report Date
    October 1, 2010
    Manufacturer
    EV3 INC.
    Product Code
    DQY
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER VIEWING THE RIGHT GROIN WHICH SUGGESTED STENOSIS IN THE RIGHT COMMON FEMORAL ARTERY, A GLIDE WIRE AND TRAILBLAZER CATHETER WAS USED; HOWEVER THE TRAILBLAZER CATHETER COULD ONLY BE ADVANCED DOWN THE MID PORTION OF THE ILIAC ARTERY. THE CATHETER WOULD NOT ADVANCE OR WITHDRAW AND UPON TRYING TO REMOVE THIS THE CATHETER SHEARED OFF LEAVING THE TIP OF THE CATHETER IN THE RIGHT ILIAC ARTERY. THE RIGHT GROIN WAS CANNULATED AND A 6 FRENCH SHEATH WAS PLACED. USING A SNARE CATHETER THE CATHETER TIP WAS REMOVED. THERE WAS SOME IRREGULARITY IN THE STENTS AND FOR THAT REASON BOTH STENTS WERE DILATED USING A "KISSING BALLOON" TECHNIQUE. FOLLOW-UP FILM SHOWED IMPROVEMENT IN THE PATENCY OF THE ILIAC STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAILBLAZER SUPPORT CATHETER DQY EV3 INC. * 8519105

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR NO OTHER THERAPIES