BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOOSE NECK? MICRO SNARE

    MDR report key: 3150585 · Received June 6, 2013

    Report

    Report Number
    2183870-2013-00140
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 8, 2013
    Manufacturer
    EV3 INC.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER IS UNAVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE SITE OF THE IVC FILTER WAS ACCESSED VIA INTERNAL JUGULAR. WHILE ATTEMPTING TO RETRIEVE A BROKEN IVC FILTER, A SMALL DARK OBJECT APPEARED UNDER FLUORO IN THE HEART. IT WAS DETERMINED THAT THE DISTAL MARKER BAND BROKE OFF THE GOOSENECK SNARE CATHETER AT THE SOME POINT DURING THE PROCEDURE. THE IVC FILTER HAD BEEN PLACED (B)(6) 2013, AND A SUPPORT STRUCTURE HAD FRACTURED, WHICH IS WHY THE PHYSICIAN DECIDED TO REMOVE IT WITH THE GOOSENECK SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251701 GOOSE NECK? MICRO SNARE CATHETER, EMBOLECTOMY DXE EV3 INC. GN2501 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention