BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCIERGE GUIDING CATHETER

    MDR report key: 1942045 · Received November 9, 2010

    Report

    Report Number
    1628221-2010-00025
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 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 EVALUATION: THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION/INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED AND COULD NOT BE DETERMINED FROM RETURNED DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD AND A REVIEW OF THE COMPLAINT DATABASE COULD NOT BE ACCOMPLISHED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION/INVESTIGATION IS COMPLETED. EVALUATION, METHOD: THE LOT NUMBER WAS NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT DATA BASE COULD NOT BE COMPLETED. CONCLUSION: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION 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. THE CATHETER WAS A LITTLE DAMAGED BEFORE USE. NO HARM OR INJURY 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