BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARQUIS SERIES STOPCOCK

    MDR report key: 2013822 · Received February 4, 2011

    Report

    Report Number
    1721504-2011-00038
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    November 24, 2010
    Report Date
    January 13, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K934123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: ONE USED SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE ROTATOR BROKE AT THE BASE OF THE COLLAR. THE MAJORITY OF THE COLLAR SURFACE BONDED TO THE ROTATOR COLLAR REMAINED INTACT WITH THE REMAINED INTACT WITH THE ROTATOR HOUSING. THE ROOT CAUSE OF THE FAILURE IS ATTRIBUTED TO AN UNUSUAL MATERIAL FAILURE WITHIN THE COLLAR. BECAUSE THE FAILURE MODE IS CONSIDERED UNUSUAL, NO CORRECTIVE ACTIONS ARE WARRANTED. EVALUATION: METHOD - THE DEVICE HISTORY RECORD WAS REVIEWED, THE COMPLAINT DATABASE WAS REVIEWED. RESULTS: UNUSUAL DEVICE FAILURE.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING A LEFT VENTRICULOGRAM PROCEDURE. THERE WAS SPRAY. INJECTOR SETTINGS: FLOW: 12 ML/SEC, VOLUME: 40 ML, PRESSURE: 900 PSI. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUIS SERIES STOPCOCK ADAPTOR, STOPCOCK, MANIFOLD, FITTING DTL MERIT MEDICAL SYSTEMS, INC. F707748

    Patients

    Seq Age Sex Outcome Treatment
    1 4 FR 110 CM STRAIGHT CATHETER| CONTRAST MEDIA