BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 5009827 · Received August 18, 2015

    Report

    Report Number
    5009827
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    April 23, 2015
    Report Date
    August 5, 2015
    Manufacturer
    EDWARDS LIFESCIENCES, LLC
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A #2 FOGARTY CATHETER WIRE UNEXPECTEDLY BROKE OFF INSIDE PATIENT'S ANTERIOR TIBIAL ARTERY BRANCH. X-RAY TAKEN, RETRIEVAL ATTEMPTED AND UNSUCCESSFUL. SURGEON DEEMED RISK FOR FURTHER INJURY WITH FURTHER ATTEMPTED REMOVAL WOULD OUT WEIGH POTENTIAL BENEFIT FROM REMOVAL. SURGEON WILL MAKE NOTE OF OCCURRENCE AS WELL. SURGEON'S DOCUMENTATION STATES: "RISK OF FURTHER EXPLORATION NOT JUSTIFIED GIVEN RESTORATION OF FLOW AND DEPTH OF DISSECTION REQUIRED IN ANTICOAGULATED PATIENT WITH RISK OF POST OPERATIVE BLEEDING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544130 ARTERIAL EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES, LLC 120602F

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR