BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERGLIDE OCCLUSION BALLOON SYSTEM

    MDR report key: 2478076 · Received March 5, 2012

    Report

    Report Number
    2029214-2012-00100
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Report Date
    February 6, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    NUF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN EVALUATED. THE EVALUATION SHOWED THAT THE GUIDEWIRE BROKE INTO TWO SEGMENTS INSIDE THE CATHETER LUMEN AND ONE OF THE SEGMENTS REMAINED INSIDE THE CATHETER.CATHETER LUMEN.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE BALLOON INFLATE WITHOUT THE GUIDEWIRE PASSED THE DISTAL TIP DURING PREPARATION.THE DEVICE WAS NOT USED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERGLIDE OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON CATHETER NUF EV3 NEUROVASCULAR 104-4108 9506627

    Patients

    Seq Age Sex Outcome Treatment
    1