BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPRESS®

    MDR report key: 13536823 · Received February 15, 2022

    Report

    Report Number
    3010665433-2022-00011
    Event Type
    Injury
    Date Received
    February 15, 2022
    Date of Event
    February 1, 2022
    Report Date
    February 2, 2022
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    UDI-DI
    00884450009215
    PMA / PMN Number
    K053171
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS BEEN RETURNED FOR EVALUATION. THE DEVICE WAS EXAMINED VISUALLY AND MICROSCOPICALLY. FUNCTIONAL TESTING WAS PERFORMED. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT DURING USE OF THE CATHETER IN THE RBI, THE CATHETER BROKE IN THE VESSEL AND COULD NOT BE REMOVED. THE REMNANTS OF THE DEVICE WERE LEFT WITHIN A STENT GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586116 IMPRESS® CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. 00884450009215 E1676931 00884450009215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention