BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRELLIS 8

    MDR report key: 2890508 · Received December 3, 2012

    Report

    Report Number
    2890508
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 3, 2012
    Manufacturer
    COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCARE
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    TRELLIS DEVICE WAS OPENED TO BREAK UP CLOT IN LEFT LEG. WE PUT IT INTO LEFT FEMORAL VEIN AND MACHINE WOULD NOT EVEN POWER ON. WE HAD TO OPEN A SECOND TRELLIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRELLIS 8 CATHETER, CONTINUOUS FLUSH KRA COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCARE * 551373

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR