BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM BALLOON SYSTEM

    MDR report key: 1834451 · Received September 10, 2010

    Report

    Report Number
    2029214-2010-00194
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 15, 2010
    Report Date
    August 15, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. (B)(4).

    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 BALLOON SYSTEM OCCLUSION BALLOON CATHETER MJN EV3 NEUROVASCULAR 104-4470 8475739

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR