BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRELLIS 8 120X30

    MDR report key: 2911151 · Received January 11, 2013

    Report

    Report Number
    2953189-2013-00003
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 5, 2012
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A RIGHT LEG DVT TRELLIS PROCEDURE THE ACCOUNT STATED THAT AFTER INSERTING DEVICE, THEY COULD NOT INFLATE THE BALLOONS. THE TRELLIS WAS REMOVED, AND A NEW DEVICE OPENED AND USED. EXAMINATION OF THE RETURNED TRELLIS SHOWED A BALLOON RUPTURE ON THE PROXIMAL BALLOON. ALL COMPONENTS ARE ACCOUNTED FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19343 TRELLIS 8 120X30 CATHETER, CONTINUOUS FLUSH KRA COVIDIEN BVT812030 551201

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other