BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGUIDE LONG TERM HEMODIALYSIS CATHETER

    MDR report key: 4173459 · Received October 10, 2014

    Report

    Report Number
    1721504-2014-00247
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 11, 2014
    Report Date
    September 16, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    MSD
    PMA / PMN Number
    K090148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: ONE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO EXCEPTION DOCUMENTS WERE FOUND. THE COMPLAINT DATABASE WAS REVIEWED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE WAS VISUALLY INSPECTED AND NO ANOMALIES WERE FOUND. THE DEVICE WAS FLOW TESTED AND WATER WAS OBSERVED PASSING THROUGH THE BIFURCATION HUB. THE COMPLAINT IS CONFIRMED. THE BIFURCATION HUB IS A PURCHASED PART. NO ROOT CAUSE WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT, DURING THE INITIAL PLACEMENT OF A HEMODIALYSIS CATHETER, A LEAK WAS FOUND IN THE CATHETER. THE DEVICE WAS EXCHANGED WITH A NEW CATHETER AND THE PROCEDURE WAS COMPLETED. NO HARM OR INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642671 PROGUIDE LONG TERM HEMODIALYSIS CATHETER CATHETER, HEMODIALYSIS, IMPLANTED MSD MERIT MEDICAL SYSTEMS, INC. H596980

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR