BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCE

    MDR report key: 4173458 · Received October 10, 2014

    Report

    Report Number
    2529252-2014-00008
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 28, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DYB
    PMA / PMN Number
    K120158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE DEVICE WAS NOT RETURNED FOR EVAL AND NO PHOTOGRAPHS ARE AVAILABLE OF THE DEVICE AT THIS TIME. THE DEVICE HISTORY WAS REVIEWED AND FOUND NO EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINT FOR THIS PRODUCT FAMILY. MERIT IS UNABLE TO DETERMINE A ROOT CAUSE AT THIS TIME DUE TO LACK OF AVAILABLE INFO AND NO COMPLAINT SAMPLE BEING RETURNED. IF THE SUSPECTED DEVICE IS RECEIVED OR ADDITIONAL INFO BECOMES AVAILABLE A FOLLOW-UP WILL BE SUBMITTED AT THAT TIME.

    Description of Event or Problem · 1

    DURING A PROCEDURE, UPON WITHDRAWAL OF THE CATHETER THE PHYSICIAN NOTICED THAT THE RADIOPAQUE BAND AT THE TIP WAS MISSING. ATTEMPTS WERE MADE TO FIND THE RADIOPAQUE BAND, BUT NOTHING WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642752 CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCE INTRODUCER, CATHETER DYB MERIT MEDICAL SYSTEMS, INC. S37804

    Patients

    Seq Age Sex Outcome Treatment
    1