BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR?

    MDR report key: 4702357 · Received April 17, 2015

    Report

    Report Number
    3005099803-2015-00949
    Event Type
    Injury
    Date Received
    April 17, 2015
    Report Date
    March 20, 2015
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(4). JOURNAL ARTICLE: FACCIOLONGO ET. AL., RECURRENT LUNG ATELECTASIS FROM FIBRIN PLUGS AS A VERY EARLY COMPLICATION OF BRONCHIAL THERMOPLASTY: A CASE REPORT, MULTIDISCIPLINARY RESPIRATORY MEDICINE, MAY 8, 2015, DOI: 10.1186/S40248-015-0002-7 THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE IN THE LUNGS. ACCORDING TO THE LITERATURE, FOUR WEEKS AFTER AN INITIAL BRONCHIAL THERMOPLASTY PROCEDURE, A SECOND BRONCHIAL THERMOPLSTY WAS PERFORMED WITH THE SAME PREMEDICATION AND DEEP SEDATION PROTOCOLS. SIXTY-ONE VALID ACTIVATIONS WERE ADMINISTERED IN THE BRONCHI OF THE LEFT LOWER LOBE. BRONCHOSCOPY SHOWED REDUCTION IN SECRETIONS AS COMPARED TO THE FIRST SESSION. SIX HOURS LATER, A SEVERE BRONCHOSPASM OCCURRED WITH RESPIRATORY FAILURE. CHEST XRAY. SHOWED A PARTIAL ATELECTASIS OF THE LEFT LOWER LOBE. A FLEXIBLE BRONCHOSCOPY ON NONINVASIVE VENTILATION SHOWED AGAIN A PLUG OCCLUDING THE LEFT LOWER LOBAR BRONCHUS. THE PLUG WAS REMOVED WITH FORCEPS FRAGMENTATION AND WASHINGS. AFTER FIVE DAYS THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257872 ALAIR? BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25020

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R