BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRELLIS 8 80X30

    MDR report key: 2891132 · Received November 14, 2012

    Report

    Report Number
    2953189-2012-00360
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    September 17, 2012
    Report Date
    November 12, 2012
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED REVEALING NO UNUSUAL CIRCUMSTANCES THAT MAY HAVE LED TO THE ISSUE REPORTED. ALL RUN PARAMETERS AND ACCEPTANCE CRITERIA WERE WITHIN THE SPECIFICATIONS. THE SAMPLE WAS RECEIVED BY THE PLANT FOR EVAL. AFTER PERFORMING VISUAL AND FUNCTIONAL INSPECTIONS, THE DEFECTIVE CONDITION WAS CONFIRMED. UPON EVAL, THERE WAS NO APPARENT DAMAGE NOTED TO THE ODU ASSEMBLY. THE ODU WAS TURNED ON, BUT THE MOTOR DID NOT ROTATE. IT WAS OBSERVED THAT THE MALE ROTATOR DISENGAGED FROM THE VALVE BACKER. THE ODU CASING WAS OPENED FOR FURTHER INVESTIGATION. THE INTERIOR OF THE ODU HAD DRIED COAGULUM. THE CATHETER WAS NOT RETURNED. A CAPA WAS OPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A TRELLIS DEVICE. THE CUSTOMER STATES THAT DURING THE FIRST DEVICE RUN IN RIGHT ILIAC VEIN SEGMENT WAS SUCCESSFUL. THE DEVICE WAS THEN REPOSITIONED TO TREAT A SECOND SEGMENT, A LOWER/DISTAL SEGMENT. THE BALLOONS WERE INFLATED AND THE DEVICE WAS TURNED ON. AT THIS POINT THERE HAD BEEN NO LYTIC ADMINISTERED. WHEN THE DEVICE TURNED ON, CONNECTION FROM CATHETER TO MECHANICAL UNIT BROKE AND DISPERSION WIRE TWISTED. AT WHICH POINT THE BALLOONS WERE DEFLATED AND THE ENTIRE DEVICE WAS REMOVED FROM THE PT. A SECOND, A NEW DEVICE WAS USED TO FINISH CASE. NO MEDICAL INTERVENTION OR PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRELLIS 8 80X30 TRELLIS KRA COVIDIEN BVT808030 551297

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK