BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EN SNARE ENDOVASCULAR SNARE SYSTEM

    MDR report key: 3101631 · Received May 3, 2013

    Report

    Report Number
    9616662-2013-00012
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    February 25, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS INC
    Product Code
    MMX
    PMA / PMN Number
    K092343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVAL. THE USER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE PLATINUM WIRE STRAND ON ONE LOOP OF THE SNARE BROKE WHILE ATTEMPTING TO COLLECT A CENTRAL VENOUS CATHETER. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195139 EN SNARE ENDOVASCULAR SNARE SYSTEM DEVICE, PERCUTANEOUS RETRIEVAL MMX MERIT MEDICAL SYSTEMS INC K419169

    Patients

    Seq Age Sex Outcome Treatment
    1