BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER

    MDR report key: 3810143 · Received April 30, 2014

    Report

    Report Number
    2529252-2014-00001
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC
    Product Code
    DYB
    PMA / PMN Number
    K120158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE WAS DISCARDED AFTER THE PROCEDURE. NO PHOTOGRAPHS WERE TAKEN OF THE DEVICE. THE DEVICE HISTORY WAS REVIEWED AND FOUND NO EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER OR 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.

    Description of Event or Problem · 1

    PER VERBAL REPORT ON (B)(4) 2014, "PT FOR DUAL CHAMBER PACEMAKER AND LV LEAD PLACEMENT. WORLEY CSG USED AS CORONARY SINUS GUIDE. AFTER REMOVAL OF THE BRAIDED CORE, BALLOON CATHETER WAS PLACED INTO THE CSG AND OCCLUSIVE CORONARY VENOGRAPHY WAS PERFORMED, SHOWING A CORONARY SINUS DISSECTION. PHYSICIAN DID NOT PLACE LV LEAD AND IMPLANT OF THE RIGHT ATRIAL LEAD WAS COMPLETED. PT REMAINED STABLE THROUGHOUT THE PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258660 CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER INTRODUCER, CATHETER DYB MERIT MEDICAL SYSTEMS, INC Q581542

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention