BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM OCCLUSION BALLOON SYSTEM

    MDR report key: 2464763 · Received February 22, 2012

    Report

    Report Number
    2029214-2012-00075
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Date of Event
    January 27, 2012
    Report Date
    January 30, 2012
    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 CATHETER AND GUIDEWIRE HAVE BEEN EVALUATED. THE EVALUATION SHOWED THAT THE GUIDEWIRE BROKE INTO TWO SEGMENTS (DUE TO TENSILE OVERLOAD) INSIDE THE CATHETER LUMEN AND ONE OF THE SEGMENTS PUNCTURED THE CATHETER LUMEN AT 1.5 CM FROM THE DISTAL TIP. CATHETER LUMEN. (B)(4).

    Description of Event or Problem · 1

    DURING BALLOON PREPARATION, IT WAS REPORTED THAT THE GUIDEWIRE WAS OBSERVED TO HAVE EXITED OUT OF THE CATHETER PRIOR TO THE DISTAL TIP. THE DEVICE WAS NOT USED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERFORM OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON CATHETER NUF EV3 NEUROVASCULAR 104-4470 9495839

    Patients

    Seq Age Sex Outcome Treatment
    1