BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT LAUREATE GUIDE WIRE

    MDR report key: 5015872 · Received August 19, 2015

    Report

    Report Number
    9616662-2015-00009
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 23, 2015
    Manufacturer
    MERIT MEDICAL IRELAND LTD.
    Product Code
    DQX
    PMA / PMN Number
    K141295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND DAMAGE TO THE WIRE COATING WAS OBSERVED 32CM FROM THE DISTAL TIP. THE COMPLAINT IS CONFIRMED. THE DAMAGE IS CONSISTENT WITH THE WIRE BEING SCORED WITH A SHARP SURFACE RESULTING IN DAMAGE TO THE WIRE COATING. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO EXCEPTION DOCUMENTS WERE FOUND. THE COMPLAINT DATABASE WAS REVIEWED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE COATING OF THE GUIDEWIRE WAS DAMAGED DURING A CROSSOVER PUNCTURE. NO PATIENT HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547712 MERIT LAUREATE GUIDE WIRE GUIDE WIRE DQX MERIT MEDICAL IRELAND LTD. K779338

    Patients

    Seq Age Sex Outcome Treatment
    1