BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLOW HPC MICRO CATHETER

    MDR report key: 539416 · Received August 16, 2004

    Report

    Report Number
    2029214-2004-00047
    Event Type
    Injury
    Date Received
    August 16, 2004
    Date of Event
    June 28, 2004
    Report Date
    July 22, 2004
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING DELIVERY OF ONYX, CATHETER RUPTURED, ONYX CAST IDENTIFIED IN THE P2, P3 SEGMENT OF THE PCA. IMMEDIATELY ANGIOGRPHY DEMONSTRATED POOR PERFUSION OF THE PCA DISTAL OF THIS CAST, FILLING THE AVM. REPEAT ANGIOGRPAHY SHOWED IMPROVED PERFUSION ALONG WITH FILLING OF THE RESIDUAL AVM. THE DRAINING VEIN WAS FULLY PATENT. THE PROCEDURE WAS ABANDONED AND URGENT APTT SENT. THE PT WAS TRANSFERRED TO INTENSIVE CARE FOR CONTINUED ELEVATION OF BLOOD PRESSURE AND HEPARINIZATION. EXTRAVASATION OF ONYX INTO THE MAINSTEM POSTERIOR CEREBRAL ARTERY NECESSITATED PREMATURE ABANDONMENT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC MICRO CATHETER FLOW-DIRECTED MICRO CATHETER KRA MICRO THERAPEUTICS, INC. 105-5065 526183

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Disability