BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRELLIS 8 80X15

    MDR report key: 1771954 · Received July 22, 2010

    Report

    Report Number
    2953724-2010-00123
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 17, 2010
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. 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) 2010, THAT A CUSTOMER HAD AN ISSUE WITH A CATHETER CONTINUOUS FLOW. THE CUSTOMER STATES THAT PATIENT'S BLOOD PRESSURE WAS NOT PALPABLE AND THE HEART RATE DROPPED FROM THE LOW 90'S TO 65. PRESSORS WERE GIVEN AND THE PATIENT WAS REMOVED FROM THE TABLE TO STABILIZE. THE PATIENT'S STABILIZED BLOOD PRESSURE WAS 185/85 POST PROCEDURE. THE CUSTOMER REPORTED THIS ISSUE PREVIOUSLY IN MFR REPORT # 2953724-2010-00112.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRELLIS 8 80X15 CATHETER CONTINUOUS FLOW KRA COVIDIEN BVT808015 P0930159

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other