BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRELLIS 8 120X25

    MDR report key: 4240477 · Received November 10, 2014

    Report

    Report Number
    2183870-2014-00282
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 12, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    PMA / PMN Number
    K130904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN.  A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.

    Description of Event or Problem · 1

    DURING THE MIDDLE OF THE TRELLIS RUN ONE OF THE BALLOONS RUPTURED. BALLOON WAS NOT TAKEN ABOVE NORMAL PRESSURES.INVESTIGATION OF THE RETURNED TRELLIS DEVICE ON OCTOBER 22, 2014 FOUND THE DISTAL BALLOON CHAMBER PROXIMAL EDGE WAS NOT ATTACHED TO THE CATHETER AND WAS PULLED OVER THE DISTAL MARKER BAND OF THE DISTAL BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723431 TRELLIS 8 120X25 CATHETER, CONTINUOUS FLUSH KRA COVIDIEN CVT812025V01 9938219

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other 8F BRIGHT TIP SHEATH