BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 1896802 · Received November 11, 2010

    Report

    Report Number
    2015691-2010-14348
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DXE
    PMA / PMN Number
    K892410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED DEFECT WAS CONFIRMED FOR BALLOON CAME OFF. THE CATHETER TIP WAS VISUALLY INSPECTED FOR INDICATION OF DAMAGE OR ABNORMALITY. THE PROXIMAL AND DISTAL WINDINGS ALONG WITH THE BALLOON LATEX HAVE BEEN PULLED OFF THE DISTAL TIP OF THE CATHETER, AND WERE NOT RETURNED. THIS CONDITION MAY OCCUR WHEN THE PULL FORCE OF 1.5 LBS (PER DIRECTIONS FOR USE) HAS BEEN EXCEEDED. THERE WAS NO OTHER DAMAGE FOUND.

    Description of Event or Problem · 1

    WHEN PULLING THE FOGARTY THROUGH THE VESSEL THE BALLOON CAME OFF THE CATHETER AND REMAINED INTRAVASCULAR. THIS OCCURED DURING A EMBOLECTOMY OF A LEFT AV FISTULA, THE PHYSICIAN WAS ATTEMPTING TO REMOVE A BLOOD CLOT AND THE VESSEL WAS SOMEWHAT CALCIFIED. PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER ARTERIAL EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES PR 120804F UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1