BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRELLIS 8 120 X 15

    MDR report key: 2597214 · Received May 30, 2012

    Report

    Report Number
    2953189-2012-00306
    Event Type
    Malfunction
    Date Received
    May 30, 2012
    Date of Event
    May 4, 2012
    Report Date
    May 4, 2012
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 05/30/2012. 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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH TRELLIS 8 120 X 15. THE CUSTOMER STATES THE TRELLIS DEVICE WAS USED TO TREAT THE RIGHT SUBCLAVIAN VEIN. THE DEVICE WAS INSERTED INTO THE PT, DEPLOYED AND TPA WAS ADMINISTERED WITHOUT ISSUE. THE DR. THEN ATTEMPTED TO ASPIRATE THE CLOT YET WAS UNSUCCESSFUL IN REMOVAL OF THE ENTIRE CLOT. THE DR THEN MADE 2 - 3 ADD'L ATTEMPTS TO ASPIRATE THE CLOT AND CONTINUED TO BE UNABLE TO REMOVE THE ENTIRE CLOT. THE DR THEN DECIDED TO REMOVE THE ENTIRE DEVICE FROM THE PT DESPITE NOT REMOVING THE ENTIRE CLOT. UPON REMOVING THE ODU FROM THE CATHETER HE ENCOUNTERED RESISTANCE AND COULD NOT REMOVE THE ODU AND DISPERSION WIRE FROM THE TRELLIS CATHETER. ADDITIONALLY, THE DR ENCOUNTERED DIFFICULTY IN DEFLATING THE DISTAL BALLOON. HE REMOVED THE SYRINGE FROM THE ODU AND REPLACED IT WITH A LARGER 30 CC SYRINGE IN ORDER TO DEFLATE THE BALLOON. THE LARGER 30 CC SYRINGE IN ADDITION TO ADD'L PRESSURE WAS ABLE TO DEFLATE THE DISTAL BALLOON. AT THIS POINT THE DR CONTINUED WITH REMOVING THE ENTIRE SYSTEM (ODU AND CATHETER) THROUGH THE SHEATH. UPON INSPECTION OF THE DEVICE, THE CATHETER APPEARED TO BE SLIGHTLY TWISTED TO THE PROXIMAL BALLOON. NO MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRELLIS 8 120 X 15 TRELLIS 8 120 X 15 KRA COVIDIEN BTV812015 551036

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK