BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIWIRE HYDROPHILIC WIRE GUIDE

    MDR report key: 3001317 · Received March 5, 2013

    Report

    Report Number
    1820334-2013-00106
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 6, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DQX
    PMA / PMN Number
    K000011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. WITHOUT THE COMPLAINT DEVICE A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NOTHING IN THE EVENT DESCRIPTION SUGGEST A POSSIBLE CAUSE. IN PREVIOUS COMPLAINTS WE HAVE FOUND POSSIBLE CAUSES TO INCLUDE DAMAGE TO THE WIRE GUIDE ASSOCIATED WITH WITHDRAWAL THROUGH THE NEEDLE (PER WARNING LABEL) OR OTHER INSTRUMENT. LESS FREQUENTLY, PATIENT ANATOMY MAKES WITHDRAWAL OF THE WIRE GUIDE DIFFICULT RESULTING IN ELONGATION AND/OR SEPARATION WHEN THE FORCE EXCEEDS DESIGN SPECIFICATION. IN THE ABSENCE OF ADDITIONAL INFORMATION A ROOT CAUSE CANNOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THERE IS INSUFFICIENT RISK PER QUALITY ENGINEERING RISK ASSESSMENT TO WARRANT RISK REDUCTION ACTIVITIES.

    Description of Event or Problem · 1

    A FEMALE PATIENT UNDERWENT PERMANENT CATHETER PLACEMENT ON (B)(6) 2013. THE DISTAL 5CM PORTION OF HYDROPHILIC COATING CAME OFF OF WIRE DURING THE PROCEDURE AND IT REMAINS INSIDE THE PATIENT. IT IS UNKNOWN TO THE INITIAL REPORTER AS TO HOW OR IF THE PORTION OF HYDROPHILIC COATING WILL BE REMOVED FROM THE PATIENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93246 HIWIRE HYDROPHILIC WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK, INC. NA 10180210

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other