BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRICUT® ANGLE-TIP BRONCHIAL BLADE

    MDR report key: 3980027 · Received August 5, 2014

    Report

    Report Number
    1045254-2014-00167
    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

    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

    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: A PATIENT DEVELOPED ¿SUBCUTANEOUS EMPHYSEMA, RIGHT PNEUMOTHORAX AND PNEUMOMEDIASTINUM AFTER JET VENTILATION AND USE OF A MICRODEBRIDER FOR EXCISING TRACHEAL PAPILLOMA. THE PATIENT AWOKE FROM ANESTHESIA WITHOUT SHORTNESS OF BREATH OR EVIDENCE OF HYPOXIA. ON ROUTINE CHEST X-RAY THE RIGHT PNEUMOTHORAX AND PNEUMOMEDIASTINUM WERE DIAGNOSED. CONSERVATIVE MEASURES WERE TAKEN AND THE RADIOLOGIC FINDINGS RESOLVED SPONTANEOUSLY AND THE PATIENT WAS OBSERVED. THE CHEST CT DID NOT REVEAL A TRACHEAL DEFECT, HOWEVER IT WAS AGREED THE PATTERN OF AIRFLOW SUGGESTED A BREACH OF THE ANTERIOR TRACHEAL WALL. IT WAS SUGGESTED THAT A SMALL MUCOSAL TEAR SPONTANEOUSLY RESOLVED AFTER JET VENTILATION CEASED.¿ THE DOCTOR HAS CONFIRMED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457702 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