BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4F OVER-THE WIRE CATHETER, 80CM

    MDR report key: 2881667 · Received December 12, 2012

    Report

    Report Number
    MW5028226
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    December 11, 2012
    Report Date
    December 12, 2012
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOGARTY CATHETER BALLOON RUPTURED WHEN THE SURGEON PULLED THE CATHETER OUT OF THE VESSEL. THE BALLOON WAS NOT VISUALIZED. UNABLE TO DETERMINE IF THE BALLOON WAS STILL IN THE VESSEL OR WAS EXPELLED BY THE INCREASED BLOOD FLOW AS THE CATHETER WAS REMOVED. DATE OF USE: (B)(6) 2012. REASON FOR USE: PLACEMENT OF LEFT FOREARM AV GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4F OVER-THE WIRE CATHETER, 80CM OVER-THE WIRE CATHETER - FOGARTY- DXE LEMAITRE VASCULAR 1651-48 OTW2034

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention