BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAUREATE HYDROPHILIC GUIDE WIRE

    MDR report key: 4939997 · Received July 24, 2015

    Report

    Report Number
    9616662-2015-00008
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    March 23, 2015
    Report Date
    June 25, 2015
    Manufacturer
    MERIT MEDICAL IRELAND LTD.
    Product Code
    DQX
    PMA / PMN Number
    K823303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE DEVICE WAS RETURNED WITHOUT ANY PACKAGING. THE WIRE WAS INSPECTED UNDER MAGNIFICATION AND 7 CM OF THE COATING WAS MISSING APPROXIMATELY 6 CM FROM THE DISTAL TIP OF THE WIRE. MULTIPLE INDENTATIONS WERE FOUND DIRECTLY PROXIMAL TO WHERE THE COATING WAS REMOVED. THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE DAMAGE TO THE WIRE COULD NOT BE DETERMINED. SINCE THE LOT NUMBER WAS NOT PROVIDED, THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    THE USER RETURNED A CATHETER WITHOUT ANY CLINICAL INFORMATION. IT IS UNKNOWN HOW THIS CATHETER WAS USED AND WHAT LED TO THE DAMAGED CONDITION OF ITS RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484113 LAUREATE HYDROPHILIC GUIDE WIRE GUIDE WIRE DQX MERIT MEDICAL IRELAND LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1