BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERGLIDE OCCLUSION BALLOON SYSTEM

    MDR report key: 2120545 · Received June 10, 2011

    Report

    Report Number
    2029214-2011-00138
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 7, 2011
    Report Date
    May 11, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED WITH THE GUIDEWIRE BROKEN IN TWO SEGMENTS INSIDE THE CATHETER. ANALYSIS OF THE CROSS SECTION AT THE BREAK POINT SHOWED THE FAILURE OF THE COREWIRE OCCURRED DUE TO FATIGUE AND MECHANICAL OVERLOAD. (B)(4)

    Description of Event or Problem · 1

    DURING PROCEDURE, IT WAS REPORTED THE GUIDEWIRE (PROVIDE WITH THE BALLOON SYSTEM) BROKE AND BLOCKED INSIDE THE CATHETER. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERGLIDE OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON CATHETER MJN EV3 NEUROVASCULAR 104-4113 9401230

    Patients

    Seq Age Sex Outcome Treatment
    1