BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYURETHANE, FLEXIBLE BRAIDED, TUBING

    MDR report key: 2142152 · Received May 26, 2011

    Report

    Report Number
    1721504-2011-00176
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTR
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE CUSTOMER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. EVALUATION METHOD: DEVICE HISTORY RECORD WAS REVIEWED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING A DIAGNOSTIC PROCEDURE OF THE CORONARY ARTERIES WHILE INJECTING CONTRAST. THE CUSTOMER REPORTED THAT THIS OCCURRED FOUR TIMES. THE DEVICES WERE DISCARDED AT THE HOSPITAL. NO HARM OR INJURY WAS REPORTED. THIS IS ONE OF FOUR REPORTS FOR THIS COMPLAINT. 1721504-2011-00173, 1721504-2011-00174, 1721504-2011-00175.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYURETHANE, FLEXIBLE BRAIDED, TUBING DISPLAY, CATHODE RAY-TUBE, MEDICAL DTR MERIT MEDICAL SYSTEMS, INC. F753360

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA