BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRICUT® ANGLE-TIP BRONCHIAL BLADE

    MDR report key: 3980010 · Received August 5, 2014

    Report

    Report Number
    1045254-2014-00166
    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: A PATIENT WHO "HAD SUPRAGLOTTIC RRP (RECURRENT RESPIRATORY PAPILLOMATOSIS) TREATED, DEVELOPED A SEVERE HEMORRHAGE THAT WAS UNABLE TO BE STOPPED ENDOSCOPICALLY. THE PATIENT REQUIRED LARYNGOPHARYNGEAL PACKING AND ANGIOGRAPHY TO HALT THE BLEEDING. UNFORTUNATELY, THIS PATIENT DEVELOPED PNEUMONIA AND DIED SHORTLY THEREAFTER." THE DOCTOR HAS CONFIRMED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458103 TRICUT® ANGLE-TIP BRONCHIAL BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC. UNKNOWN TRICUT BLADE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention