BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRAFLOW HPC FLOW-DIRECTED MICRO CATHETER

    MDR report key: 441674 · Received February 5, 2003

    Report

    Report Number
    2029214-2003-00004
    Event Type
    Other
    Date Received
    February 5, 2003
    Date of Event
    November 22, 2002
    Report Date
    January 27, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN AVM EMBOLIZATION, THERE WAS A CATHETER RUPTURE DURING THE ONYX EMBOLIC INJECTION. ONYX HAD BEEN SUCCESSFULLY INJECTED THROUGH THE CATHETER, BUT THE EVENT OCCURRED AFTER THREE TWO-MINUTE INJECTION INTERRUPTIONS DUE TO REFLUX. THE PHYSICIAN FELT SOME RESISTANCE DURING THE ONYX INJECTION PRIOR TO THE RUPTURE, BUT CONTINUED WITH THE INJECTION. A SMALL AMOUNT OF ONYX WAS IN THE PARENT VESSEL. A SECTION OF THE CATHETER REMAINS ENTRAPPED IN THE AVM. THE PATIENT DID NOT EXPERIENCE ANY CLINICAL SEQUELAE RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC FLOW-DIRECTED MICRO CATHETER NEURO MICRO CATHETER KRA MICRO THERAPEUTICS, INC. 105-5065 892694J

    Patients

    Seq Age Sex Outcome Treatment
    1 *