BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 5014475 · Received August 19, 2015

    Report

    Report Number
    3005099803-2015-02335
    Event Type
    Injury
    Date Received
    August 19, 2015
    Date of Event
    December 17, 2014
    Report Date
    July 24, 2015
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, 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 ON (B)(6) 2013 AS PART OF THE (B)(4) STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ACUTE BRONCHITIS TREATED WITH MEDICATION. ON (B)(6) 2013, THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT AND LEFT UPPER LOBES OF THE LUNGS. NO ISSUES WERE NOTED TO THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014 THE PATIENT EXPERIENCED ACUTE BRONCHITIS. THE PATIENT ALSO EXPERIENCED COUGH (PRODUCTIVE AND NON-PRODUCTIVE), DYSPNEA, FATIGUE, FEVER, OTALGIA, WHEEZE, PHARYNGITIS, POST NASAL DISCHARGE, NASAL CONGESTION, SINUS PRESSURE, AND HEADACHE. THE PATIENT WAS TREATED WITH ZPACK, MEDROL DOSE PACK, TESSALON PERLES, CLARITIN, NORTRIPTYLINE, AND AMOXICILLIN. ON (B)(6) 2015 THE EVENT WAS CONSIDERED TO BE RESOLVED. BASELINE SPIROMETRY VALUES; VISIT DATE: (B)(6) 2012. PRE-BRONCHODILATOR; FEV1: 2.27. FEV1 % PREDICTED: 88.67 FVC: 3.70; FVC % PREDICTED: 124.16; POST-BRONCHODILATOR; FEV1: 2.76; FEV1 % PREDICTED: 107.81; FVC: 3.69; FVC % PREDICTED: 123.83.

    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 ON (B)(6) 2013 AS PART OF THE (B)(4) STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ACUTE BRONCHITIS TREATED WITH MEDICATION. ON (B)(6) 2013, THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT AND LEFT UPPER LOBES OF THE LUNGS. NO ISSUES WERE NOTED TO THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014, THE PATIENT EXPERIENCED ACUTE BRONCHITIS. THE PATIENT ALSO EXPERIENCED COUGH (PRODUCTIVE AND NON-PRODUCTIVE), DYSPNEA, FATIGUE, FEVER, OTALGIA, WHEEZE, PHARYNGITIS, POST NASAL DISCHARGE, NASAL CONGESTION, SINUS PRESSURE, AND HEADACHE. THE PATIENT WAS TREATED WITH ZPACK, MEDROL DOSE PACK, TESSALON PERLES, CLARITIN, NORTRIPTYLINE, AND AMOXICILLIN. ON (B)(6) 2015, THE EVENT WAS CONSIDERED TO BE RESOLVED. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2012. PRE-BRONCHODILATOR: FEV1: 2.27; FEV1 % PREDICTED: 88.67; FVC: 3.70; FVC % PREDICTED: 124.16. POST-BRONCHODILATOR: FEV1: 2.76; FEV1 % PREDICTED: 107.81; FVC: 3.69; FVC % PREDICTED: 123.83. ADDITIONAL INFORMATION RECEIVED ON 09SEP2015. THIS ADVERSE EVENT, ACUTE BRONCHITIS, IS NO LONGER DEEMED RELATED TO PROCEDURE DUE TO THE TIME THAT HAS PASSED SINCE THE LAST PROCEDURE. ACCORDING TO THE SITE, ALL THE SYMPTOMS REPORTED ASSOCIATED WITH THIS EVENT OF BRONCHITIS WERE NOT RELATED TO THE BT PROCEDURE. THE COMPLAINT OF BRONCHITIS AND ALL SYMPTOMS REPORTED HAVE BEEN RESCINDED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547069 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010 CM-112712-003

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention