BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLOW HPC FLOW-DIRECTED MICRO CATHETER

    MDR report key: 488877 · Received October 10, 2003

    Report

    Report Number
    2029214-2003-00039
    Event Type
    Malfunction
    Date Received
    October 10, 2003
    Date of Event
    September 10, 2003
    Report Date
    September 10, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS FOR THE EMBOLIZATION OF A LARGE TEMPORAL AVM. ONYX LIQUID EMBOLIC WAS INJECTED OVER A 44 MINUTE PERIOD. DURING THE PROCEUDRE, THE CATHETER WAS ENTRAPPED IN REFLUXED ONYX, AND UPON REMOVAL, SEPARATED APPROXIAMTELY 10CM FROM THE DISTAL TIP. THE REMAINING SECTION OF CATHETER WAS LEFT IN THE BASILAR ARTERY. THE REFLUX EAS NOT READILY VISIBLE, AS THERE WAS A SECONDARY PEDICLE BEHIND THE ACCESS PEDICLE, WHICH MADE VISUALIZATION AND THE ABILITY TO DISTINQUISH BETWEEN THE TWO VESSELS DIFFICULT. THE PHYSICIAN WAS SATISFIED WITH THE INJECTION WHICH TREATED A SIGNIFICANT PART OF THE AVM. THERE WAS NO PATIENT COMPLICATION.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ONYX LIQUID EMBOLIC.