BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM OCCLUSION BALLOON SYSTEM

    MDR report key: 2504473 · Received March 26, 2012

    Report

    Report Number
    2029214-2012-00182
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Date of Event
    January 11, 2012
    Report Date
    February 28, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    NUF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE BALLOON COULD NOT BE VISUALIZED DURING PROCEDURE. OUTSIDE OF THE PATIENT, THE BALLOON WAS TESTED AND INFLATED WITHOUT THE GUIDEWIRE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERFORM OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON CATHETER NUF EV3 NEUROVASCULAR 104-4470 9444730

    Patients

    Seq Age Sex Outcome Treatment
    1