BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM OCCLUSION BALLOON SYSTEM

    MDR report key: 2371406 · Received October 12, 2011

    Report

    Report Number
    2029214-2011-00333
    Event Type
    Malfunction
    Date Received
    October 12, 2011
    Date of Event
    August 25, 2011
    Report Date
    September 30, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    NUF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON CATHETER WAS RETURNED FOR EVALUATION WITH THE GUIDEWIRE STUCK INSIDE THE CATHETER. THE GUIDEWIRE WAS FOUND BROKEN INTO TWO SEGMENTS INSIDE THE CATHETER. ANALYSIS OF THE CROSS SECTION AT THE BREAK POINT COULD NOT DETERMINED THE CAUSE OF THE GUIDEWIRE FAILURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE BALLOON WAS USED DURING PROCEDURE AND THE PHYSICIAN RETRIEVE IT AS HE FELT UNUSUAL WITH THE CATHETER. OUTSIDE OF THE PT, THE PHYSICIAN TESTED THE CATHETER FOR INFLATION AND NOTICE THE DISTAL TIP OF THE GUIDEWIRE WAS DAMAGED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERFORM OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON CATHETER NUF EV3 NEUROVASCULAR 104-4470 9434983

    Patients

    Seq Age Sex Outcome Treatment
    1