BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON-10, 45 TIP SHAPED MICRO CATHETER

    MDR report key: 602529 · Received May 13, 2005

    Report

    Report Number
    2029214-2005-00032
    Event Type
    Injury
    Date Received
    May 13, 2005
    Date of Event
    April 13, 2005
    Report Date
    May 13, 2005
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COILING OF CEREBRAL ANEURYSM IN A 40 YRS OLD GRADE 1 SAH 2 DAYS POST ICTUS. ON INSPECTION OF THE DEVICE, TIP SHAPED OF THE CATHETER WAS NOTED TO BE SHAPED-25' RATHETER THAN 45'. ENTRY INTO ANEURYSM STRAIGHT FORWARD WITH MICROWIRE. WHILE ADVANCING THE MICRO CATHETER INTO THE ANEURYSM, THE PT SUDDENLY BECAME ACUTELY HYPERTENSIVE. CHECK ANGIOGRAPHY REVEALED RUPTURE OF THE ANEURYSM. A COIL WAS RAPIDLY DEPLOYED INTO THE MICRO CATHETER BUT WENT STRAIGHT THROUGH THE ANEURYSM (AS THE TRUE TIP OF THE CATHETER WHICH WAS NOT MARKED WAS RIGHT THOUGH THE ANEURYSM). ON REALIZING THAT THE DISTAL MARKER OF THE CATHETER WAS ABSENT, THE CATHETER WAS WITHDRAWN, AN ALTERNATE SELECT CATHETER WAS PLACED TO THE ANEURYSM AND THE ANEURYSM WAS RAPIDLY COILED. THE PT WAS NOT ANTICOAGULATED, CT SCAN SHOWED FURTHER FRESH BLOOD IN THE SYLVIAN FISSURE AND HYDROCEPHALUS. THE PT WAS EXTRUBATED AND HAS MADE A FULL RECOVERY WITH HYPERTENSIVE RX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON-10, 45 TIP SHAPED MICRO CATHETER DELIVERY CATHETER KRA MICRO THERAPEUTICS, INC. 145-5091-150 1049055

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening