BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLOW HPC 1.5F

    MDR report key: 1840237 · Received September 15, 2010

    Report

    Report Number
    2029214-2010-00199
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    February 8, 2010
    Report Date
    August 17, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN RETURNED AND EVALUATED. A RUPTURE WAS FOUND AT APPROXIMATELY 18 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". RESULTS - CATHETER RUPTURE. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN AVM WITH ONYX. IT WAS REPORTED THE CATHETER RUPTURED DURING PROCEDURE. NO PATIENT INJURY REPORTED. SAME EVENT AS MDR# 2029214-2010-00200.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC 1.5F FLOW DIRECTED MICRO CATHETER KRA EV3 NEUROVASCULAR 105-5065 7700630

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK