BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EN SNARE

    MDR report key: 2247683 · Received September 8, 2011

    Report

    Report Number
    9616662-2011-00054
    Event Type
    Injury
    Date Received
    September 8, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    MMX
    PMA / PMN Number
    K092343
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE CUSTOMER REPORTED A SECOND POSSIBLE LOT NUMBER OF K221033 FOR THE DEVICE. EXPIRATION DATE: 02/28/2014. DEVICE MANUFACTURE DATE: 03/2011. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE TRYING TO REMOVE A URETERAL STENT THE LOOPS ON THE SNARE BROKE. A NEW SNARE WAS USED TO REMOVE THE BROKEN SNARE LOOP AND THE URETERAL STENT. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EN SNARE DEVICE, PERCUTANEOUS RETRIEVAL MMX MERIT MEDICAL SYSTEMS, INC. P770021

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SALINE| CONTRAST MEDIA