BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM OCCLUSION BALLOON SYSTEM

    MDR report key: 3121724 · Received May 21, 2013

    Report

    Report Number
    2029214-2013-00480
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 23, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON CATHETER WAS RETURNED FOR EVALUATION WITHOUT THE GUIDEWIRE AND THE BALLOON WAS FOUND TO BE RUPTURED FROM THE DISTAL TO PROXIMAL MARKER BAND SIMILAR TO THE BURST CHARACTERIZATION DUE TO FAST INFLATION SPEEDS. THE IFU (INSTRUCTIONS FOR USE) HAS A WARNING, "DO NOT EXCEED THE MAXIMUM RECOMMENDED INFLATION VOLUME AS BALLOON RUPTURE MAY OCCUR."BALLOON RUPTURE.(B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING PREPARATION, THE BALLOON RUPTURED ON THE FIRST INFLATION TEST. NO INJURY WAS REPORTED WITH THE PATIENT AS THE DEVICE WAS NOT USED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223910 HYPERFORM OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON SYSTEM MJN EV3 NEUROVASCULAR 104-4471 9666939

    Patients

    Seq Age Sex Outcome Treatment
    1