BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM ANGIOGRAPHIC KIT

    MDR report key: 1791329 · Received August 6, 2010

    Report

    Report Number
    1721504-2010-00222
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    June 15, 2010
    Report Date
    July 13, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K934123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ¿ THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT EVALUATION/INVESTIGATION IS NOT COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO EXCEPTION DOCUMENTS. COMPLAINT DATA BASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATA BASE WAS REVIEWED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING A LEFT VENTRICULOGRAM PROCEDURE. THIS HAPPENED TWICE. THERE WAS NO REPORT OF HARM OR INJURY. THIS IS ONE OF TWO REPORTS FOR THIS COMPLAINT. 1721504-2010-00223.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ANGIOGRAPHIC KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. F731063

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA