BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK MEDICAL MEDLINE COPE MANDRIL WIRE GUIDE

    MDR report key: 10810476 · Received November 6, 2020

    Report

    Report Number
    MW5097708
    Event Type
    Injury
    Date Received
    November 6, 2020
    Date of Event
    October 1, 2020
    Report Date
    November 4, 2020
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PERCUTANEOUS RENAL PROCEDURE- DRAIN BEING PLACED PRIOR TO SCHEDULED STONE REMOVAL. THE GUIDEWIRE BROKE INSIDE THE PATIENT. WHILE THE MD WAS ATTEMPTING TO REPOSITION FOR BETTER PLACEMENT, THE WIRE TIP SHEARED OFF. PATIENT HAS BEEN INFORMED. SHE HAS A SCHEDULED PROCEDURE IN THE OPERATING ROOM TODAY- REMOVAL OF THE STONE. SHE WILL HAVE THAT AND THEY WILL TRY TO REMOVE THE WIRE AT THAT TIME. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262969 COOK MEDICAL MEDLINE COPE MANDRIL WIRE GUIDE WIRE, GUIDE, CATHETER DQX COOK MEDICAL LLC 13294543

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention