BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRICUT® ANGLE-TIP BRONCHIAL BLADE

    MDR report key: 3980174 · Received August 5, 2014

    Report

    Report Number
    1045254-2014-00173
    Event Type
    Injury
    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

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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: ¿PATIENT WITH EXTENSIVE LARYNGEAL PAPILLOMA DEVELOPED A MASSIVE HEMORRHAGE DURING USE OF THE MICRODEBRIDER REQUIRING INTRAOPERATIVE LARYNGEAL PACKING TO STABILIZE THE PATIENT PRIOR TO ANGIOGRAPHY AFTER ENDOSCOPIC MEASURES TO CONTROL THE BLEEDING WERE UNSUCCESSFUL. THE PATIENT WAS INTUBATED FOR FOUR DAYS BEFORE THE PACKING WAS REMOVED IN THE OPERATING ROOM. THE PATIENT DID WELL WITHOUT PERMANENT SEQUELAE.¿ THE DOCTOR HAS CONFIRMED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458262 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