BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM OCCLUSION BALLOON SYSTEM

    MDR report key: 1200048 · Received October 15, 2008

    Report

    Report Number
    2029214-2008-00183
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 22, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    DURING PREPARATION, IT WAS REPORTED THE BALLOON COULD NOT BE DEFLATED AFTER INFLATION TEST. 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 MJN EV3 NEUROVASCULAR 104-4470 5409471

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK