BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAGLE EYE GOLD CATHETER

    MDR report key: 836945 · Received April 10, 2007

    Report

    Report Number
    2939520-2007-00005
    Event Type
    Injury
    Date Received
    April 10, 2007
    Date of Event
    February 20, 2007
    Report Date
    April 9, 2007
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    ITX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN USED THE EAGLE GOLD CATHETER TO EXAMINE THE SHUNTING POINT OF A DIALYSIS PATIENT. THE RADIAL ARTERY WAS PUNCTURED AND A 6F SHEATH WAS INSERTED INTO THE ARTERY. THE CATHETER BECAME TRAPPED AT THE TIP OF THE SHEATH AND DETACHED. A SNARED WAS ATTEMPTED, BUT UNSUCCESSFUL. THE PATIENT WAS TAKEN TO SURGERY AND THE DETACHED TIP WAS REMOVED. PATIENT WAS REPORTED TO BE IN GOOD CONDITION. THE CATHETER HAS NOT RETURNED FOR EVALUATION; THEREFORE, FURTHER ANALYSIS CANNOT BE COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    DISTAL TIP OF CATHETER TRAPPED AT THE TIP OF THE SHEATH AND DETACHED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention