BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCIERGE GUIDING CATHETER

    MDR report key: 1934351 · Received November 23, 2010

    Report

    Report Number
    1628221-2010-00030
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 2, 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

    ONE USED DEVICE WAS RECEIVED FOR EVALUATION/INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. 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. METHOD: THE DEVICE HISTORY RECORD WAS REVIEWED. 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. 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. E102052

    Patients

    Seq Age Sex Outcome Treatment
    1