BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 5027413 · Received August 25, 2015

    Report

    Report Number
    3005099803-2015-02276
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 28, 2015
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED AS THE DEVICE WAS DISPOSED AND NOT RETURNED FOR ANALYSIS. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE DFU LISTS PNEUMONIA AS A POSSIBLE ADVERSE EVENT THAT MAY OCCUR WITH THE USE OF THIS DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ANTICIPATED PROCEDURAL COMPLICATION.

    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) 2015 AS PART OF THE BSC BT REGISTRY CLINICAL STUDY. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2015, THE PATIENT UNDERWENT THE SECOND BRONCHIAL THERMOPLASTY PROCEDURE TO THE LEFT LOWER LOBE OF THE LUNGS. NO ISSUES WERE NOTED TO THE DEVICE. ON (B)(6) 2015, THE PATIENT DEVELOPED PNEUMONIA AND WAS TREATED WITH MEDICATION (TYPE OF MEDICATION NOT REPORTED). ON (B)(6) 2015, THE EVENT WAS CONSIDERED TO BE RESOLVED. BASELINE SPIROMETRY VALUES VISIT DATE: (B)(6) 2015 PRE-BRONCHODILATOR FEV1: 2.89 FEV1 % PREDICTED: 98.00 FVC: 4.17 FVC % PREDICTED: 112.00 POST-BRONCHODILATOR FEV1: 2.89 FEV1 % PREDICTED: 101.00 FVC: 4.37 FVC % PREDICTED: 117.00.

    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) 2015 AS PART OF THE (B)(4) STUDY. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2015, THE PATIENT UNDERWENT THE SECOND BRONCHIAL THERMOPLASTY PROCEDURE TO THE LEFT LOWER LOBE OF THE LUNGS. NO ISSUES WERE NOTED TO THE DEVICE. ON (B)(6) 2015, THE PATIENT DEVELOPED PNEUMONIA AND WAS TREATED WITH MEDICATION (TYPE OF MEDICATION NOT REPORTED). ON (B)(6) 2015, THE EVENT WAS CONSIDERED TO BE RESOLVED. BASELINE SPIROMETRY VALUES VISIT DATE: (B)(6) 2015 PRE-BRONCHODILATOR FEV1: 2.89 FEV1 % PREDICTED: 98.00 FVC: 4.17 FVC % PREDICTED: 112.00 POST-BRONCHODILATOR FEV1: 2.89 FEV1 % PREDICTED: 101.00 FVC: 4.37 FVC % PREDICTED: 117.00 ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2015. THE MEDICATION ADMINISTERED TO TREAT THIS EVENT IS AS FOLLOWS: AMOXICILLIN AND CLAVULANIC 875/125MG EVERY 8 HOURS FOR 7 DAYS, AS WELL AS AZITHROMYCIN 500MG/DAY DURING 3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562538 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25020 16894339

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention