BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE

    MDR report key: 3952632 · Received July 18, 2014

    Report

    Report Number
    MW5037351
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A 3.5 X 100MM COYOTE OVER THE WIRE BALLOON USED TO TREAT A LESION IN THE LEFT LEG BELOW THE KNEE. WE DECIDED TO CHANGE WIRES TO ADVANCE THE SYSTEM FURTHER SO AN ATTEMPT TO CHANGE THE WIRES OUT WAS MADE. THE NEW 0.014 WIRE WOULD NOT INSERT AND PASS BEYOND THE HUB OF THE BALLOON. NOT EVEN THE STIFF SIDE OF THE WIRE WOULD PASS. IN ORDER TO SAVE PLACEMENT AND GET A WIRE DOWN INTO THE FAR SIDE OF THE LESION WE HAD TO CUT THE HUB OFF AND WE WERE SUCCESSFUL AT PLACING THE NEW WIRE DISTAL TO THE LESION AND RETRIEVING THE BALLOON SHAFT BACK OUT OF THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423139 COYOTE BALLOON LIT BOSTON SCIENTIFIC COYOTE 15289832

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other 6 FR ANSEL 1| 300CM CONFIENTA PRO 12| 300CM SPARTACORE