BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR?

    MDR report key: 3787329 · Received May 2, 2014

    Report

    Report Number
    3005099803-2014-01808
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    March 22, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    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 SINUSITIS TREATED WITH ANTIBIOTIC. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER SECOND BRONCHIAL THERMOPLASTY TREATMENT TO THE LEFT LOWER LOBE OF THE LUNG ON (B)(6) 2014. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPNEA, WHEEZE, AND HEADACHE DUE TO SINUSITIS. THE PATIENT WAS TREATED WITH BACTRIM AND PREDNISONE. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT. THE EVENT WAS REPORTED RESOLVED ON (B)(6) 2014. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2014, PRE-BRONCHODILATOR: FEV1: 2.56, FEV1 % PREDICTED: 93.77, FVC: 3.03, FVC % PREDICTED: 87.57. POST-BRONCHODILATOR: FEV1: 2.59, FEV1 % PREDICTED: 94.87, FVC: 3.05, FVC % PREDICTED: 88.15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264306 ALAIR? BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010 CM-011713-027

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention