BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR

    MDR report key: 6848247 · Received September 7, 2017

    Report

    Report Number
    3005099803-2017-02742
    Event Type
    Injury
    Date Received
    September 7, 2017
    Date of Event
    February 28, 2016
    Report Date
    October 3, 2019
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY SOURCE: (B)(6). (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. UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 16, 2019.

    Additional Manufacturer Narrative · 1

    (B)(6). STUDY SOURCE: E7086 BSC BT REGISTRY. 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 BT PROCEDURE PERFORMED ON (B)(6) 2016 AS PART OF THE (B)(6) STUDY. ON (B)(6) 2016 THE PATIENT WAS ADMITTED FOR THE BT PROCEDURE AS PLANNED BY THE PHYSICIAN. ON (B)(6) 2016 THE PATIENT UNDERWENT THE FIRST BT TREATMENT TO THE RIGHT LOWER LOBE OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2016, WHILE HOSPITALIZED FOR OBSERVATION FOLLOWING THE BT PROCEDURE, THE PATIENT EXPERIENCED POST-PROCEDURE BRONCHOSPASM, COUGH, AND WHITISH EXPECTORATION. THE PATIENT WAS TREATED WITH PREDNISONE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2016 AS PLANNED BY THE PHYSICIAN FOR PROPHYLACTIC REASONS. ON (B)(6) 2016 THE PATIENT EXPERIENCED UPPER RESPIRATORY TRACT INFECTION (URTI) AND WAS TREATED WITH MEDICATION (EXACT TYPE NOT REPORTED). NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED DUE TO THIS EVENT. ON (B)(6) 2016 THE URTI HAD RESOLVED. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2016, (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BT PROCEDURE PERFORMED ON (B)(6) 2016 AS PART OF THE BSC (B)(6) STUDY. ON (B)(6) 2016 THE PATIENT WAS ADMITTED FOR THE BT PROCEDURE AS PLANNED BY THE PHYSICIAN. ON (B)(6) 2016 THE PATIENT UNDERWENT THE FIRST BT TREATMENT TO THE RIGHT LOWER LOBE OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2016, WHILE HOSPITALIZED FOR OBSERVATION FOLLOWING THE BT PROCEDURE, THE PATIENT EXPERIENCED POST-PROCEDURE BRONCHOSPASM, COUGH, AND WHITISH EXPECTORATION. THE PATIENT WAS TREATED WITH PREDNISONE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2016 AS PLANNED BY THE PHYSICIAN FOR PROPHYLACTIC REASONS. ON (B)(6) 2016 THE PATIENT EXPERIENCED UPPER RESPIRATORY TRACT INFECTION (URTI) AND WAS TREATED WITH MEDICATION (EXACT TYPE NOT REPORTED). NO HOSPITALIZATIONS OR ER VISITS OCCURRED DUE TO THIS EVENT. ON (B)(6) 2016 THE URTI HAD RESOLVED. BASELINE SPIROMETRY VALUES VISIT DATE: (B)(6) 2016: PRE-BRONCHODILATOR, FEV1: 2.64, FEV1 % PREDICTED: 66.10, FVC: 4.01, FVC % PREDICTED: 83.50. POST-BRONCHODILATOR: FEV1: 3.71, FEV1 % PREDICTED: 93.10, FVC: 5.04, FVC % PREDICTED: 105.00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628337 ALAIR BRONCHIAL THERMOPLASTY SYSTEM OOY M005ATS25020 0017994933

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention