BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERGLIDE OCCLUSION BALLOON SYSTEM

    MDR report key: 2112114 · Received June 2, 2011

    Report

    Report Number
    2029214-2011-00122
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON CATHETER HAS BEEN EVALUATED AND CONFIRMED THE CATHETER INFLATED AT APPROXIMATELY 7.2 CM FROM THE DISTAL TIP OF THE CATHETER. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE BALLOON WAS INFLATED, A SEGMENT OF THE CATHETER SHAFT PROXIMAL TO THE BALLOON ASSEMBLY WAS ALSO INFLATED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERGLIDE OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON CATHETER MJN EV3 NEUROVASCULAR 104-4112 7213604

    Patients

    Seq Age Sex Outcome Treatment
    1