BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-CROSS RF CROSSING WIRE

    MDR report key: 586303 · Received March 23, 2005

    Report

    Report Number
    2031958-2005-00001
    Event Type
    Malfunction
    Date Received
    March 23, 2005
    Date of Event
    February 23, 2005
    Report Date
    February 23, 2005
    Manufacturer
    INTRALUMINAL THERAPEUTICS, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ILT SAFE-CROSS RF CROSSING WIRE WAS USED IN AN ATTEMPT TO CROSS A TOTAL OCCLUSION OF THE RIGHT COMMON ILIAC ARTERY TO ENABLE PERCUTANEOUS THERAPEUTIC TREATMENT WITH OTHER DEVICES. AFTER APPROXIMATELY 1 HOUR OF INTRAVASCULAR MANIPULATION ATTEMPTING TO CROSS THE OCCLUSION THE WIRE BROKE NEAR THE DISTAL TIP. THE DISTAL PORTION OF THE WIRE WAS SNARED AND REMOVED THROUGH THE GUIDE CATHETER. THE PT EXPERIENCED NO ADVERSE EFFECTS ATTRIBUTABLE TO THE WIRE BREAKAGE AND/OR TIP RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE-CROSS RF CROSSING WIRE CATHETER GUIDE WIRE DQX INTRALUMINAL THERAPEUTICS, INC. G218AN1 070604

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other 4F GLIDE CATHETER USED DURING THE PROCEDURE WITH| THE SAFE-CROSS RF CROSSING WIRE.