BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 4122315 · Received September 18, 2014

    Report

    Report Number
    1125782-2014-00012
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE KIT IS NOT EXPECTED TO BE RETURNED FOR INVESTIGATION. 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 CHRONIC OCCLUSION REVASCULARIZATION PROCEDURE OF THE SFA, A CLOT WAS REMOVED FROM THE ARTERY USING A FILTER WIRE. THE PHYSICIAN OBSERVED BLUE FIBROUS MATERIAL IN THE CLOT. THE WIRE USED IN THE PROCEDURE WAS WIPED USING GAUZE AND SOAKED IN A BOWL OF SALINE TO MAINTAIN LUBRICITY. THE PHYSICIAN BELIEVES THAT THE FIBERS CAME FROM THE SURGICAL GOWN OR DRAPE INCLUDED IN THE KIT AND WERE TRANSFERRED TO THE WIRE WHILE IT WAS WIPED. NO FURTHER HARM OR INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578890 MERIT CUSTOM KIT DQO MERIT MEDICAL SYSTEMS, INC. T629173

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention