BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK MOTION HYBRID WIRE GUIDE

    MDR report key: 10991575 · Received December 10, 2020

    Report

    Report Number
    MW5098311
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    December 4, 2020
    Report Date
    December 8, 2020
    Manufacturer
    COOK, INC.
    Product Code
    DQX
    UDI-DI
    00827002448469
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A CYSTOSCOPY, A COOK MOTION HYBRID WIRE GUIDE (MHW-035150; G44846), LOT NUMBER: 9006229355 WAS PLACED IN THE LEFT URETER IN PREPARATION FOR A STENT PLACEMENT. IT WAS NOTED THE BLUE WIRE COATING (NITINOL WITH HYDROPHILIC TIP) CAME OFF WIRE AND WAS IN THE BLADDER. YOU CAN SEE ON THE PICTURE, THE END OF THE WIRE IS MISSING THE BLUE COATING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454303 COOK MOTION HYBRID WIRE GUIDE WIRE, GUIDE, CATHETER DQX COOK, INC. MHW-035150 9006229355 00827002448469

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other