BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR?

    MDR report key: 3983495 · Received August 6, 2014

    Report

    Report Number
    3005099803-2014-02741
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 9, 2014
    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).

    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 CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2014 AS PART OF THE (B)(4) STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ATELECTASIS TREATED WITH MEDICATION. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT LOWER LOBE ON (B)(6) 2014. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED ATELECTASIS AND WAS TREATED WITH MEDICATION. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT. THE EVENT IS REPORTED AS CONTINUING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BASELINE SPIROMETRY VALUES. VISIT DATE: (B)(6) 2014. PRE-BRONCHODILATOR, FEV1: 2.06, FEV1 % PREDICTED: 75.00, FVC: 3.25, FVC % PREDICTED: 95.00. POST-BRONCHODILATOR, FEV1: 2.26, FEV1 % PREDICTED: 82.00, FVC: 3.30, FVC % PREDICTED: 96.00.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2014 AS PART OF THE (B)(4) STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ATELECTASIS TREATED WITH MEDICATION. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT LOWER LOBE ON (B)(6) 2014. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED ATELECTASIS AND WAS TREATED WITH MEDICATION. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT. THE EVENT IS REPORTED AS CONTINUING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BASELINE SPIROMETRY VALUES. VISIT DATE: (B)(6) 2014. PRE-BRONCHODILATOR- FEV1: 2.06; FEV1 % PREDICTED: 75.00; FVC: 3.25; FVC % PREDICTED: 95.00. POST-BRONCHODILATOR- FEV1: 2.26; FEV1 % PREDICTED: 82.00; FVC: 3.30; FVC % PREDICTED: 96.00. ADDITIONAL INFORMATION RECEIVED AS OF SEPTEMBER 10, 2014. THE REPORTED EVENT OF ATELECTASIS WAS REPORTED TO HAVE RESOLVED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460059 ALAIR? BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25020 16635930

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention