BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM BALLOON SYSTEM

    MDR report key: 1840209 · Received September 15, 2010

    Report

    Report Number
    2029214-2010-00198
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 17, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE BALLOON RUPTURED DURING PREPARATION. NO PATIENT INJURY REPORTED. SAME EVENT AS MDR# 2029214-2010-00197.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERFORM BALLOON SYSTEM OCCLUSION BALLOON CATHETER MJN EV3 NEUROVASCULAR 104-4771 8496855

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK