BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLOW HFC 1.5F

    MDR report key: 729782 · Received June 16, 2006

    Report

    Report Number
    2029214-2006-00075
    Event Type
    Malfunction
    Date Received
    June 16, 2006
    Date of Event
    May 10, 2006
    Report Date
    May 18, 2006
    Manufacturer
    EV3 NEUROVASCULAR DIVISION
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN RETURNED AND EVALUATED. A RUPTURE IS OBSERVED IN THE DISTAL SEGMENT OF THE CATHETER. THE DEVICE HISTORY RECORDS FOR THE REPORTED PRODUCT LOT NUMBER HAVE BEEN REVIEWED AND NO QUALITY ISSUE WERE NOTED. THE APPEARANCE OF THE CATHETER IS CONSISTANT WITH A RUTPURE CAUSED BY CATHETER OVER-PRESSURIZATION. THIS IS MOST LIKELY TO OCCUR DURING INJECTION OF CONTRAST WHEN THE DISTAL PORTION OF THE CATHETER IS KINKED OR OCCLUDED.

    Description of Event or Problem · 1

    THE CATHETER RUPTURED DURING CONTRAST INJECTION. NO COMPLICATION WERE REPORTED TO HAVE OCCURRED WITH THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HFC 1.5F FLOW DIRECTED MICRO CATHETER KRA EV3 NEUROVASCULAR DIVISION 105-5065 1421270

    Patients

    Seq Age Sex Outcome Treatment
    1 *