BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVIGO HYDROPHILIC GUIDEWIRE

    MDR report key: 2840749 · Received November 20, 2012

    Report

    Report Number
    2029214-2012-00609
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED.(B)(4).

    Description of Event or Problem · 1

    POST PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN MENTIONED THAT THERE WAS A SMALL DISSECTION OF THE VESSEL; HOWEVER, THE PHYSICIAN DID NOT MENTION THAT IT WAS CAUSED BY THE AVIGO GUIDEWIRE.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVIGO HYDROPHILIC GUIDEWIRE GUIDEWIRE DQX EV3 NEUROVASCULAR 103-0606-200 9588194

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability