BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRICUT® ANGLE-TIP BRONCHIAL BLADE

    MDR report key: 3980225 · Received August 5, 2014

    Report

    Report Number
    1045254-2014-00175
    Event Type
    Death
    Date Received
    August 5, 2014
    Report Date
    July 12, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: 1898200T MICRODEBRIDER; 1898200T IGS M4 510K: K041413 ERL. (B)(4). PRODUCT EVALUATION: NO ANALYSIS RESULTS AVAILABLE. DEVICES WILL NOT BE RETURNED FOR EVALUATION. METHOD: NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC THAT A PHYSICIAN WAS NOTIFIED BY A COLLEAGUE, THAT SOMETIME WITHIN THE PAST 10 YEARS, THE FOLLOWING ACCOUNT OCCURRED WHEN A MICRODEBRIDER WAS BEING USED WITH THE TRICUT BLADE: DURING A CASE IN WHICH THE MICRODEBRIDER WAS USED ¿FOR SUBGLOTTIC STENOSIS AND REMOVAL OF GRANULATION TISSUE¿, THE PATIENT SUSTAINED ¿INTRAOPERATIVE DAMAGE TO THE INNOMINATE ARTERY¿ WHICH RESULTED IN A ¿HEMORRHAGIC COMPLICATION¿ AND ULTIMATELY, DEATH. THE DOCTOR HAS CONFIRMED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457564 TRICUT® ANGLE-TIP BRONCHIAL BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. UNKNOWN TRICUT BLADE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other