BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM OCCLUSION BALLOON SYSTEM

    MDR report key: 2602036 · Received June 6, 2012

    Report

    Report Number
    2029214-2012-00283
    Event Type
    Malfunction
    Date Received
    June 6, 2012
    Date of Event
    May 9, 2012
    Report Date
    May 10, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    NUF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON CATHETER WAS RETURNED FOR EVALUATION WITHOUT THE GUIDEWIRE.THE BALLOON WAS TESTED FOR INFLATION/DEFLATION AND NO DEFECT WAS FOUND. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE BALLOON COULD NOT BE DEFLATED 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 9494644

    Patients

    Seq Age Sex Outcome Treatment
    1