BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERGLIDE OCCLUSION BALLOON SYSTEM

    MDR report key: 3980221 · Received August 5, 2014

    Report

    Report Number
    2029214-2014-00464
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 7, 2014
    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 CATHETER WAS RETURNED FOR EVALUATION WITH THE GUIDEWIRE. THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT AS IT PERFORMED AS INTENDED WITH THE RETURNED GUIDEWIRE. ALL DEVICES ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. (B)(4)

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING PREPARATION, IT WAS REPORTED THE BALLOON HAD AN ABNORMAL SHAPE AND HAD DIFFICULTIES DEFLATING ON THE TABLE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458325 HYPERGLIDE OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON SYSTEM MJN EV3 NEUROVASCULAR 104-4112 9888768

    Patients

    Seq Age Sex Outcome Treatment
    1