BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM OCCLUSION BALLOON SYSTEM

    MDR report key: 2398112 · Received January 4, 2012

    Report

    Report Number
    2029214-2012-00002
    Event Type
    Malfunction
    Date Received
    January 4, 2012
    Date of Event
    December 5, 2011
    Report Date
    December 7, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    NUF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EVALUATED AND CONFIRMED THE BALLOON WAS RUPTURE. (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 HYPERFORM OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON CATHETER NUF EV3 NEUROVASCULAR 104-4470 9428975

    Patients

    Seq Age Sex Outcome Treatment
    1