BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRELLIS 8 80X30

    MDR report key: 1968984 · Received January 18, 2011

    Report

    Report Number
    2953724-2011-00002
    Event Type
    Other
    Date Received
    January 18, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2011. 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 A CATHETER, CONTINUOUS FLOW. THE CUSTOMER REPORTS THAT AFTER THE SECOND RUN OF TRELLIS WAS COMPLETED AND ASPIRATION HAD STARTED, THE PATIENT BECAME TACHYCARDIC, DYSPNEIC, AND NAUSEATED. HIS BASELINE VITALS WERE: HR (B)(6)'S, O2 SATS ON 2L/NC WERE 100%, AND BP WAS APPROXIMATELY 115/60. DURING THE ASPIRATION, THE PATIENT'S O2 SATS DROPPED TO APPROXIMATELY 86% AND HIGHER OXYGEN REQUIREMENTS WERE NEEDED, UP TO 6L/NC WITH THIS O2 SATS RETURNED TO 99%, HR WAS ELEVATED TO AS HIGH AS 100 AND BP WAS AT ONE POINT 190/70. ZOFRAN WAS GIVEN WITH SOME RELIEF OF NAUSEA. NURSING STAFF ALSO NOTED THAT THE PATIENT BEGAN SHAKING. THE 25 MG OF DEMEROL WAS GIVEN. EVENTUALLY ALL VITAL SIGNS HAD RETURNED TO BASELINE AND PATIENT WAS NO LONGER REPORTING NAUSEA OR DISCOMFORT. DURING THIS EPISODE, THE PATIENT REMAINED ALERT AND ORIENTED TO PERSON, PLACE, AND TIME AND HAD NO MOTOR DEFICIENCIES. IT SHOULD BE NOTED THAT THE PATIENT HAD AN IVC FILTER PLACED THROUGH THE RIGHT JUGULAR ACCESS PRIOR TO THE TRELLIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRELLIS 8 80X30 CATHETER, CONTINUOUS FLOW KRA COVIDIEN BVT808030 P0930156

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other