BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2043381 · Received February 25, 2011

    Report

    Report Number
    9616662-2011-00016
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 13, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K884913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE GAUGE ON THE INFLATOR WOULD NOT SHOW PRESSURE WHILE INFLATING A BALLOON IN THE CORONARY ARTERY. THE CUSTOMER COULD SEE UNDER FLUOROSCOPY THAT THE BALLOON WAS INFLATED. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. K186498

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA| BALLOON