BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASIX COMPAK INFLATION SYRINGE

    MDR report key: 2160440 · Received June 20, 2011

    Report

    Report Number
    9616662-2011-00038
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K884913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE EVAL HAS NOT BEEN COMPLETED. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED. EVAL, CONCLUSIONS: A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE WHILE INFLATING A BALLOON THE PRESSURE GAUGE STOPPED AT 12 BARS THEN JUMPED TO 18 BARS. THE CUSTOMER CONTINUED TO USE THE DEVICE AS THEY REPORTED THAT THIS OCCURRED AT THREE DIFFERENT STAGES DURING THE PROCEDURE. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASIX COMPAK INFLATION SYRINGE INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT MERIT MEDICAL SYSTEMS, INC. K228487

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR SALINE| VISIPAQUE CONTRAST MEDIA| PTCA BALLOON