BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERGLIDE BALLOON SYSTEM

    MDR report key: 1860368 · Received September 24, 2010

    Report

    Report Number
    2029214-2010-00205
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 28, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON CATHETER WAS RETURNED FOR EVAL WITH THE GUIDEWIRE. THE BALLOON WAS TESTED FOR INFLATION/DEFLATION AND NO DEFECT WAS FOUND. (B)(4).

    Description of Event or Problem · 1

    DURING PREPARATION, IT WAS REPORTED, THE BALLOON DEFLATED VERY SLOWLY AFTER INFLATION TEST. THE DEVICE WAS NOT USED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERGLIDE BALLOON SYSTEM OCCLUSION BALLOON CATHETER MJN EV3 NEUROVASCULAR 104-4112 7077452

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK