BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 1881368 · Received October 7, 2010

    Report

    Report Number
    2029214-2010-00220
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 9, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN RETURNED AND EVALUATED. A RUPTURE WAS FOUND AT APPROXIMATELY 7.2 CM FROM THE DISTAL TIP. THE APPEARANCE OF THE CATHETER IS CONSISTENT WITH A RUPTURE CAUSED BY OVER-PRESSURIZATION AS A RESULT OF AN UNDETECTED KINK OR OTHER OBSTRUCTION WITHIN THE CATHETER. THE IFU INCLUDES A WARNING "WHEN INJECTING CONTRAST FOR ANGIOGRAPHY, ENSURE THAT THE CATHETER IS NOT KINKED, PROLAPSED OR OCCLUDED." CATHETER RUPTURE. (B)(4).

    Description of Event or Problem · 1

    DURING AN ANGIOGRAPHIC INJECTION WITH CONTRAST, IT WAS REPORTED A LEAK WAS NOTED PROXIMAL OF THE CATHETER. THE CATHETER WAS REMOVED FROM THE PT AND IT WAS FOUND RUPTURED AT APPROXIMATELY 1CM FROM THE DISTAL TIP. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARATHON MICRO CATHETER FLOW DIRECTED MICRO CATHETER KRA EV3 NEUROVASCULAR 105-5055 8622377

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK