BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRELLIS 8 80X30

    MDR report key: 1701667 · Received May 25, 2010

    Report

    Report Number
    2953724-2010-00110
    Event Type
    Injury
    Date Received
    May 25, 2010
    Date of Event
    May 7, 2010
    Report Date
    May 7, 2010
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 05/07/2010 THAT A CUSTOMER HAD AN ISSUE WITH A CATHETER, CONTINUOUS FLOW. THE CUSTOMER REPORTS THAT THE MOTOR DRIVE SLOWED TO A STOP DURING THE SECOND RUN. THE DOCTOR ATTEMPTED TO DEFLATE THE BALLOONS AND NEITHER WOULD COLLAPSE. THE ODU WIRE COULD NOT BE EXTRACTED FROM THE CATHETER. THE DOCTOR CUT THE CATHETER AND THE ODU WIRE TO ATTEMPT TO GAIN LEVERAGE TO REMOVE THE WIRE, TO NO AVAIL. THE DOCTOR DEFLATED THE BALLOONS WITH 2 PERCUTANEOUS PUNCTURES. THE TRELLIS WAS ULTIMATELY REMOVED AFTER A SHORT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRELLIS 8 80X30 CATHETER, CONTINUOUS FLOW KRA COVIDIEN BVT808030 P0930167

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other