BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT HEMOSTASIS VALVE

    MDR report key: 2210419 · Received August 8, 2011

    Report

    Report Number
    9616662-2011-00048
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K925419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED. EVAL, METHOD: DEVICE HISTORY RECORD WAS REVIEWED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE ROTATOR BROKE. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER REPORTED THAT THIS EVENT OCCURRED THREE TIMES OVER THE PAST TWO MONTHS. HOWEVER, THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFO OR CLINICAL DETAILS FOR THE ADD'L EVENTS. THEREFORE THIS SINGLE FORM FDA 3500A WILL BE SUBMITTED FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT HEMOSTASIS VALVE ADAPTOR, STOPCOCK, MANIFOLD, FITTING DTL MERIT MEDICAL SYSTEMS, INC. W759700

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRES