BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRELLIS 6 120X30

    MDR report key: 1790597 · Received August 3, 2010

    Report

    Report Number
    2953724-2010-00124
    Event Type
    Other
    Date Received
    August 3, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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 TRELLIS DEVICE. THE CUSTOMER REPORTS HE BELIEVES THE PROXIMAL BALLOON OF THE T6 CAUSED A PERFORATION TO THE POSTERIOR TIBIAL VEIN. THE CUSTOMER REPORTS NO MEDICAL INTERVENTION WAS REQUIRED DUE TO THE FACT IT IS A VERY SMALL VESSEL AND WILL HEAL ON ITS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRELLIS 6 120X30 CATHETER CONTINUOUS FLOW KRA COVIDIEN BVT612030 P10-30191

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other