BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCIERGE GUIDING CATHETER

    MDR report key: 1971793 · Received November 22, 2010

    Report

    Report Number
    1628221-2010-00028
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 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 - ONE USED DEVICE WAS RECEIVED FOR EVALUATION/INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT DATA BASE COULD NOT BE COMPLETED. THE DEVICE WAS VISUALLY EXAMINED AND THE COMPLAINT CONFIRMED. THE CATHETER HAD DIAGONAL KINKS ALONG THE CATHETER SHAFT. UNABLE TO DETERMINE AN EXACT ROOT CAUSE. NO CONCLUSION CAN BE DRAWN. COMPLAINTS WILL BE MONITORED FOR THIS TYPE OF FAILURE. EVALUATION: METHOD, NO LOT NUMBER PROVIDED, UNABLE TO REVIEW THE DEVICE HISTORY RECORD OR COMPLAINT DATA BASE. RESULTS: UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE CATHETERS ARE KINKING DURING THE PROCEDURE. NO HARM OR INJURY REPORTED. THE CUSTOMER REPORTED TWO (2) DEFECTIVE DEVICES BUT HAS NOT PROVIDED ANY ADDITIONAL INFORMATION OR CLINICAL DETAILS FOR THE ADDITIONAL EVENT. THIS SINGLE FORM FDA 3500A REPORT WILL BE SUBMITTED FOR THIS COMPLAINT.

    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