BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCIERGE GUIDING CATHETER

    MDR report key: 1931268 · Received November 11, 2010

    Report

    Report Number
    1628221-2010-00026
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQY
    PMA / PMN Number
    K043387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE DEVICE EVAL/INVESTIGATION IS NOT COMPLETE. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD AND A REVIEW OF THE COMPLAINT DATA BASE COULD NOT BE COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. EVAL, METHOD: UNABLE TO PERFORM A DEVICE HISTORY RECORD AND COMPLAINT DATA BASE REVIEW. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    THE CATHETER KINKED DURING MANIPULATION INTO THE OSTIUM OF THE RIGHT CORONARY ARTERY FOR A PTCA PROCEDURE. NO HARM OR INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCIERGE GUIDING CATHETER CATHETER, PERCUTANEOUS DQY MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA