BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EN SNARE®

    MDR report key: 4899007 · Received July 8, 2015

    Report

    Report Number
    9616662-2015-00007
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    April 21, 2015
    Report Date
    June 16, 2015
    Manufacturer
    MERIT MEDICAL IRELAND LTD.
    Product Code
    MMX
    PMA / PMN Number
    K092343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND THE MARKER BAND WAS NOT ATTACHED TO THE CATHETER. THE COMPLAINT WAS CONFIRMED. THE CATHETER SHOWED EVIDENCE THAT THE MARKER BAND HAD BEEN ATTACHED. THE MARKER BAND WAS NOT RETURNED WITH THE CATHETER. WITHOUT THE ENTIRE DEVICE TO EVALUATE, THE ROOT CAUSE OF THE FAILURE CANNOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO EXCEPTION DOCUMENTS WERE FOUND. A CORRECTIVE ACTION IS IN PROCESS TO ADDRESS THIS FAILURE MODE.

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RETURNED FOR EVALUATION. THE EVALUATION IS IN-PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, THE MARKER BAND ON THE CATHETER BECAME DETACHED. WHILE THE CATHETER WAS BEING PULLED THROUGH A LESION RESISTANCE WAS FELT. THE CATHETER WAS REMOVED AND THE MARKER BAND WAS MISSING. THE MARKER BAND WAS FOUND IN THE LOCATION WHERE THE STENT WAS PLANNED. THE STENT WAS DEPLOYED OVER THE LESION AND MARKER BAND. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442180 EN SNARE® EN SNARE ENDOVASCULAR SNARE SYSTEM MMX MERIT MEDICAL IRELAND LTD. K658737

    Patients

    Seq Age Sex Outcome Treatment
    1