BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOOSE NECK¿ MICRO SNARE

    MDR report key: 2213778 · Received August 17, 2011

    Report

    Report Number
    2183870-2011-00158
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 21, 2011
    Manufacturer
    EV3 INC.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE A LOT NUMBER WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    DURING A PDA CLOSURE PROCEDURE THE PHYSICIAN WAS ATTEMPTING TO SNARE A COIL. THE HOOP OF THE GOOSENECK SNARE FRACTURED AND THEY PHYSICIAN HAD TO USE ANOTHER SNARE TO REMOVE THE HOOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOOSE NECK¿ MICRO SNARE CATHETER, EMBOLECTOMY DXE EV3 INC. SK700 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention