BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRELLIS 6 120X30

    MDR report key: 2231087 · Received July 20, 2011

    Report

    Report Number
    2953189-2011-00038
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Report Date
    July 8, 2011
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    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 (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH AN ELECTROSURGICAL DEVICE. THE CUSTOMER REPORTS THE DISTAL BALLOON BURST IMMEDIATELY UPON INFLATION. THE PHYSICIAN ABORTED THE CASE AND PLACED A DRIP CATHETER OF THROMBOLYTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRELLIS 6 120X30 ELECTROSURGICAL DEVICE KRA COVIDIEN BVT612030 550257

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK