BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 2171832 · Received July 22, 2011

    Report

    Report Number
    2015691-2011-15899
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER IS NOT AVAILABLE FOR EVALUATION; IT WAS DISCARDED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET SPECIFICATION UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER HAD A CRACK AT THE SHAFT JUST BEFORE THE BALLOON. THE BALLOON COULD NOT BE DEFLATED AND THE DOCTOR PUNCTURED THE PATIENT'S SKIN WITH A NEEDLE TO DEFLATE THE BALLOON. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. THIS FACILITY PERFORMS DIALYSIS ON PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES, PR 120404F 59008934

    Patients

    Seq Age Sex Outcome Treatment
    1