BEUDAMED
    FDA Adverse Event Other Summary report: N

    EAGLE EYE GOLD

    MDR report key: 793698 · Received December 1, 2006

    Report

    Report Number
    2939520-2006-00003
    Event Type
    Other
    Date Received
    December 1, 2006
    Date of Event
    November 2, 2006
    Report Date
    November 30, 2006
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE REMAINING CATHETER WAS RETURNED TO VOLCANO CORP FOR EVAL. VISUAL AND MICROSCOPIC EXAMINATION INDICATED THE INNER LUMEN FAILED DUE TO THE FORCE USED TO FREE THE CATHETER. THE DISTAL TIP, SCANNER AND PORTION (APPROXIMATELY 30CM) OF THE MICROCABLE WAS MISSING. THIS WAS A MATERIAL BREAK AND NOT AN ADHESIVE BOND BREAK. IT WAS NOTICED THAT THE PROXIMAL END OF THE CATHETER SHAFT WAS BENT IN A WAY CONSISTENT WITH IT BEING WRAPPED AROUND A HUMAN HAND. THE CATHETER WAS MANUFACTURED TO SPECS. THE CATHETER WAS REMOVED WITH SIGNIFICANT FORCE TO CAUSE THE MATERIAL BREAK.

    Description of Event or Problem · 1

    CATHETER DISTAL END CAUGHT IN STENT, CATHETER WAS STRONGLY PULLED AND CATHETER TIP DETACHED. TIP REMOVAL WAS ATTEMPTED BY USING A SNARE, BUT WAS UNSUCCESSFUL. DISTAL TIP OF CATHETER REMAINS IN PT CAUGHT IN STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAGLE EYE GOLD INTRAVASCULAR ULTRASONIC CATHETER ITX VOLCANO CORPORATION 85900 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other