BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERGLIDE OCCLUSION BALLOON SYSTEM

    MDR report key: 2380735 · Received November 1, 2011

    Report

    Report Number
    2029214-2011-00354
    Event Type
    Malfunction
    Date Received
    November 1, 2011
    Date of Event
    September 15, 2011
    Report Date
    October 3, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    NUF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN EVALUATED AND WAS FOUND PUNCTURED BY THE GUIDEWIRE APPROXIMATELY 1.5CM FROM THE DISTAL TIP. THE GUIDEWIRE WAS ALSO FOUND BROKEN INTO TWO SEGMENTS. ANALYSIS OF THE BREAK POINT SHOWED THE FAILURE OF THE GUIDWIRE OCCURRED DUE TO OVERLOAD.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE BALLOON RUPTURED DURING PREPARATION. THE DEVICE WAS NOT USED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERGLIDE OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON CATHETER NUF EV3 NEUROVASCULAR 104-4112 9391000

    Patients

    Seq Age Sex Outcome Treatment
    1