BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAUREATE GUIDE WIRE

    MDR report key: 6980222 · Received October 26, 2017

    Report

    Report Number
    9616662-2017-00028
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    October 12, 2017
    Report Date
    October 18, 2017
    Manufacturer
    MERIT MEDICAL IRELAND LTD.
    Product Code
    DQX
    PMA / PMN Number
    K141295
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ONE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE PRODUCT WAS EXAMINED VISUALLY. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE WAS ATTRIBUTED TO THE CONCOMITANT DEVICE. A REVIEW OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO EXCEPTION DOCUMENTS WERE FOUND.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTS THAT DURING A PERCUTANEOUS LASER-FACILITATED THROMBECTOMY PROCEDURE THE LASER DEVICE MELTED THE HYDROPHILIC GUIDE WIRE CAUSING THROMBOSIS WITHIN THE PATIENT'S ARTERY. A THROMBOASPIRATION CATHETER AND FEMORAL ARTERY BYPASS WAS REQUIRED TO SUCCESSFULLY TREAT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760572 LAUREATE GUIDE WIRE GUIDE WIRE DQX MERIT MEDICAL IRELAND LTD. K1107551

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R