BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERCROSS

    MDR report key: 1962608 · Received January 12, 2011

    Report

    Report Number
    MW5018985
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    October 24, 2010
    Report Date
    January 4, 2011
    Manufacturer
    EV3, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PROTECTIVE BALLOON SHEATH FOR THE EV3 DILATATION BALLOON WAS RETAINED FROM PROCEDURE THE DAY BEFORE (UNK AT THE TIME). THE SHEATH WAS REMOVED DURING SURGERY THE NEXT DAY. THE PROBLEM WAS THAT THE PROTECTIVE SHEATH WAS NOT DETECTED AND REMOVED BY SURGICAL TECH. THE PROTECTIVE SHEATH IS CLEAR. RECOMMEND COLORING OF SHEATH FOR EASY IDENTIFICATION. DATES OF USE: (B)(6). DIAGNOSIS OR REASON FOR USE: DIABETIC GANGRENE OF LEFT FOOT TOES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVERCROSS DILATATION CATHETER DQY EV3, INC. 3MM X 20MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other