BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM OCCLUSION BALLOON SYSTEM

    MDR report key: 2472483 · Received February 29, 2012

    Report

    Report Number
    2029214-2012-00085
    Event Type
    Malfunction
    Date Received
    February 29, 2012
    Date of Event
    February 6, 2012
    Report Date
    February 7, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    NUF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON CATHETER HAS BEEN EVALUATED AND FOUND RUPTURED AT THE DISTAL MARKER BAND. THIS LIKELY PREVENTED THE BALLOON FROM MAINTAIN INFLATION.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE BALLOON COULD NOT STAYED INFLATE DURING PREPARATION. 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 104-4770 9329055

    Patients

    Seq Age Sex Outcome Treatment
    1