BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPRESS PERIPHERAL CATHETER

    MDR report key: 6675611 · Received June 28, 2017

    Report

    Report Number
    3010665433-2017-00038
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    June 6, 2017
    Report Date
    June 21, 2017
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC
    Product Code
    DQO
    PMA / PMN Number
    K053171
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    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

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO EXCEPTION DOCUMENTS WERE FOUND. A REVIEW OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND.

    Description of Event or Problem · 1

    MEDWATCH 5070269 STATED "THE TIP OF THE CATHETER SHEARED OFF WHEN RETRACTING THE CATHETER OVER A WIRE THROUGH A 6F GUIDE CATHETER ADJACENT TO A STAGHORN CALCULUS. THE 4F CATHETER BOUND ADJACENT TO THE STONE. THE GUIDE WIRE REMAINED THROUGH THE FRAGMENT AND DOWN TO THE BLADDER. OVER THE WIRE AN 8F SHEATH WAS PLACED AND THE FRAGMENT REMOVED SUCCESSFULLY. NO INJURY TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454189 IMPRESS PERIPHERAL CATHETER PERIPHERAL CATHETER DQO MERIT MEDICAL SYSTEMS, INC E1096977

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention