BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISI-PRO PTA BALLOON CATHETER

    MDR report key: 1082268 · Received July 24, 2008

    Report

    Report Number
    2183870-2008-00098
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN ANOTHER COUNTRY. SMA (SUPERIOR MESENTERIC ARTERY) X 2. NINETY PERCENT PROXIMAL - STENTED USING 8 X 37 50% DISTAL, THE 2ND STENT GOT CAUGHT ON MEDICAL STRUTS OF 1ST STENT AND THEN DISLODGED OFF BALLOON. RETRIEVAL USING GOOSENECK SNARE WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISI-PRO PTA BALLOON CATHETER FGE EV3 INC. PXB35-07-27-080 4622226

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other GOOSENECK SNARE