BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR?

    MDR report key: 3812015 · Received May 15, 2014

    Report

    Report Number
    3005099803-2014-01867
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 17, 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)(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 (BT) PROCEDURE ON (B)(6) 2014 AS PART OF THE (B)(4) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ASTHMA EXACERBATION LEADING TO HOSPITALIZATION AND THE PATIENT WAS TREATED WITH MEDICATION. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT 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 WHEEZE POST PROCEDURE. LATER THAT EVENING, SUBJECT ALSO EXPERIENCED COUGH, CHEST DISCOMFORT, AND SHORTNESS OF BREATH. THE SYMPTOMS PERSISTED SO THE PATIENT WENT TO THE ER ON (B)(6) 2014 AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS TREATED WITH IV SOLU-MEDROL, ALBUTEROL, ATROVENT NEBULIZER, NEBULIZED LIDOCAINE, ORAL STEROIDS, TESSALON PERLES, GUAIFENESIN WITH CODEINE, NSAIDS, AND NON-OPIOID ANALGESICS. THE PATIENT TESTED POSITIVE FOR INFLUENZA B. IT HAS BEEN REPORTED THAT THE INFLUENZA IS NOT CONSIDERED TO BE RELATED TO THE BT PROCEDURE. THE SYMPTOMS IMPROVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. THE EVENT OF ASTHMA EXACERBATION IS REPORTED AS RESOLVED AS OF (B)(6) 2014. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2014. PRE-BRONCHODILATOR: FEV1: 2.82, FEV1 % PREDICTED: 94.95, FVC: 4.39, FVC % PREDICTED: 125.07. POST-BRONCHODILATOR: FEV1: 3.10, FEV1 % PREDICTED: 104.38, FVC: 4.52, FVC % PREDICTED: 128.77.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291857 ALAIR? BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010 CM-011513-003

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R