BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR?

    MDR report key: 3873121 · Received June 13, 2014

    Report

    Report Number
    3005099803-2014-02227
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). STUDY SOURCE: POST-FDA APPROVAL CLINICAL TRIAL EVALUATING BRONCHIAL THERMOPLASTY IN SEVERE PERSISTENT ASTHMA ((B)(4)). THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 PNEUMONIA. 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 BEGAN EXPERIENCING EXACERBATED ASTHMA AND WAS TREATED WITH PREDNISONE. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT. ON (B)(6) 2014, THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH CHEST TIGHTNESS AND A FEVER > 38 C. A CT SCAN WAS PERFORMED, REVEALING PNEUMONIA. THE PATIENT WAS SENT HOME WITH A PRESCRIPTION FOR LEVAQUIN. NO HOSPITALIZATIONS OCCURRED AS RESULT OF THIS EVENT. THE EVENT WAS REPORTED AS CONTINUING. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2014. PRE-BRONCHODILATOR: FEV1: 2.48; FEV1 % PREDICTED: 79.49; FVC: 3.49; FVC % PREDICTED: 92.08. POST-BRONCHODILATOR: FEV1: 2.73; FEV1 % PREDICTED: 87.50; FVC: 3.64; FVC % PREDICTED: 96.04. ADDITIONAL INFORMATION RECEIVED AS OF JUNE 16, 2014. THE REPORTED EVENT OF ASTHMA AGGRAVATED WAS REPORTED TO HAVE RESOLVED ON (B)(6) 2014. THE REPORTED EVENT OF PNEUMONIA WAS REPORTED TO HAVE RESOLVED ON (B)(6) 2014.

    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) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF PNEUMONIA. 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 BEGAN EXPERIENCING EXACERBATED ASTHMA AND WAS TREATED WITH PREDNISONE. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT. ON (B)(6) 2014 THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH CHEST TIGHTNESS AND A FEVER > 38 C. A CT SCAN WAS PERFORMED, REVEALING PNEUMONIA. THE PATIENT WAS SENT HOME WITH A PRESCRIPTION FOR LEVAQUIN. NO HOSPITALIZATIONS OCCURRED AS RESULT OF THIS EVENT. THE EVENT WAS REPORTED AS CONTINUING. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2014. PRE-BRONCHODILATOR: FEV1: 2.48, FEV1 % PREDICTED: 79.49, FVC: 3.49, FVC % PREDICTED: 92.08. POST-BRONCHODILATOR: FEV1: 2.73, FEV1 % PREDICTED: 87.50, FVC: 3.64, FVC % PREDICTED: 96.04.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350008 ALAIR? BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010 CM-012513-017

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR