BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAUREATE GUIDE WIRE

    MDR report key: 7075542 · Received December 1, 2017

    Report

    Report Number
    9616662-2017-00031
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    October 25, 2017
    Report Date
    November 8, 2017
    Manufacturer
    MERIT MEDICAL IRELAND LTD
    Product Code
    DQX
    PMA / PMN Number
    K141295
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A REVIEW OF THE COMPLAINT DATABASE AND DEVICE HISTORY RECORD COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGES THAT DURING PLACEMENT OF A DOUBLE J-CURVE URETERAL STENT OVER A HYDROPHILIC GUIDEWIRE THE TIP DETACHED IN THE PATIENT. THE TIP DETACHMENT WAS NOTICED IN THE PATIENT KIDNEY BY THE PHYSICIAN DURING A FOLLOW-UP APPOINTMENT TWO WEEKS LATER. ON (B)(6) 2017 THE PHYSICIAN ADMITTED THE PATIENT AND REMOVED THE WIRE FRAGMENT FROM THE PATIENT'S KIDNEY USING A FLEXIBLE SCOPE WITH A SNARE DEVICE. THE EVENT WAS NOT CONSIDERED LIFE THREATENING BY THE PHYSICIAN AND DID NOT RESULT IN PERMANENT DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855635 LAUREATE GUIDE WIRE GUIDEWIRE DQX MERIT MEDICAL IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization DOUBLE J-CURVE STENT| UTERSCOPE