BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER

    MDR report key: 1842420 · Received September 23, 2010

    Report

    Report Number
    2015691-2010-14098
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DXE
    PMA / PMN Number
    K892410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IT WAS UNABLE TO DEFLATE THE BALLOON DURING SET UP." DEVICE WILL NOT BE RETURNED DUE TO THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES PR 12TLW804F UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1