BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 6441636 · Received March 28, 2017

    Report

    Report Number
    3005099803-2017-00802
    Event Type
    Injury
    Date Received
    March 28, 2017
    Date of Event
    October 16, 2015
    Report Date
    March 2, 2017
    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 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 PERFORMED ON (B)(6) 2015 AS PART OF THE (B)(4) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF DYSPNEA REQUIRING MEDICATION TO TREAT (EXACT MEDICATION NOT REPORTED). ON (B)(6) 2015 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BT PROCEDURE. ON (B)(6) 2015 THE PATIENT UNDERWENT THE FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT LOWER LOBE OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. THE PATIENT WAS DISCHARGED ON (B)(6) 2015. THE PATIENT'S HOSPITALIZATION FROM (B)(6) 2015 WAS A PLANNED HOSPITALIZATION FOR THE BT PROCEDURE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2015 THE PATIENT EXPERIENCED DYSPNEA AND WAS TREATED WITH MEDICATION OR REGIMEN WAS ADJUSTED, ALTHOUGH THE EXACT MEDICATION WAS NOT REPORTED (NO SYSTEMIC CORTICOSTEROID WAS ADMINISTERED). ON (B)(6) 2015 THE DYSPNEA WAS RESOLVED. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2015. PRE-BRONCHODILATOR: FEV1: 1.71; FEV1 %: 71; FVC: 3.10; FVC% PREDICTED: 109.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222048 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25020 17482751

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention