BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EN SNARE ENDOVASCULAR SNARE SYSTEM

    MDR report key: 5066085 · Received September 9, 2015

    Report

    Report Number
    9616662-2015-00014
    Event Type
    Injury
    Date Received
    September 9, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 17, 2015
    Manufacturer
    MERIT MEDICAL IRELAND LTD.
    Product Code
    MMX
    PMA / PMN Number
    K092343
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO EXCEPTION DOCUMENTS WERE FOUND. BECAUSE THE UNIT WAS NOT RETURNED, THE ROOT CAUSE COULD NOT BE DETERMINED. IF THE DEVICE IS RETURNED IN THE FUTURE THIS INVESTIGATION WILL BE REOPENED AND A FOLLOW UP SUBMITTED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING THE REMOVAL OF NEPHROSTOMY FRAGMENTS FROM A PATIENT THE HEAD OF THE SNARE DETACHED FROM THE SHAFT WHILE ATTEMPTING TO PULL THE SNARE THROUGH THE SHEATH TRACT. THE SNARE HEAD AND NEPHROSTOMY FRAGMENT WERE LODGED IN THE TISSUE TRACT A FEW CENTIMETERS BELOW THE SKIN. THE SNARE HEAD AND NEPHROSTOMY FRAGMENTS WERE REMOVED AT A LATER DATE. NO FURTHER PATIENT INJURY OR HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597305 EN SNARE ENDOVASCULAR SNARE SYSTEM ENDOVASCULAR SNARE MMX MERIT MEDICAL IRELAND LTD. K557085

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention