BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM OCCLUSION BALLOON SYSTEM

    MDR report key: 2950099 · Received February 8, 2013

    Report

    Report Number
    2029214-2013-00123
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 17, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE BALLOON CATHETER WAS RETURNED FOR EVALUATION AND IT WAS NOT FOUND RUPTURED AS REPORTED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON WAS FOUND RUPTURED DURING PREPARATION. THE DEVICE WAS NOT USED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54656 HYPERFORM OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON SYSTEM MJN EV3 NEUROVASCULAR 104-4470 9619758

    Patients

    Seq Age Sex Outcome Treatment
    1