BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2160258 · Received June 2, 2011

    Report

    Report Number
    9616662-2011-00035
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K884913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE CUSTOMER DID NOT REPORT A LOT NUMBER. THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE CUSTOMER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED. EVALUATION METHOD: DEVICE HISTORY RECORD COULD NOT BE REVIEWED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE WHEN THE PHYSICIAN INFLATED THE BALLOON, THE NEEDLE INSIDE THE PRESSURE GAUGE FELL AND THE PRESSURE DECREASED. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DXT MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE| BALLOON| CONTRAST MEDIA