BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRELLIS 6 120X30

    MDR report key: 1894165 · Received November 4, 2010

    Report

    Report Number
    2953724-2010-00136
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 16, 2010
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A CATHETER, CONTINUOUS FLOW. THE CUSTOMER STATED THAT DURING THE TRELLIS CASE WHEN INITIATING THROMBOLYTIC (T-PA) INFUSION, COMPLETE RESISTANCE OF INFUSION HAPPENED. CUSTOMER STATED THE INFUSION LUMEN SEEMED TO BE BLOCKED. THROMBOLYTIC WAS THEN GIVEN THROUGH THE ASPIRATION PORT INSTEAD. CASE WAS COMPLETED WITH COMPLETE INFUSION AND THEN ASPIRATION. CUSTOMER STATED THAT THE CATHETER ALSO LEAKED AT MANIFOLD OF PORTS. CUSTOMER STATES THAT POST TRELLIS, UPON INSPECTION OF DEVICE, WHEN THEY ATTEMPTED TO INFUSE THROUGH THE INFUSION PORT THE DISTAL BALLOON INFLATED WHILE FORCE WAS GIVEN TO THE INFUSION PORT. UPON INVESTIGATION REVIEW IT APPEARED THAT THE CATHETER SHAFT BROKE INTO TWO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRELLIS 6 120X30 CATHETER, CONTINUOUS FLOW KRA COVIDIEN BVT612030 P1030258

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN