BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 2884640 · Received December 24, 2012

    Report

    Report Number
    3005099803-2012-06126
    Event Type
    Injury
    Date Received
    December 24, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 30, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). MFR NAME: BOSTON SCIENTIFIC CORPORATION (B)(4). STUDY SOURCE: (B)(4). A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL SPECIFICATION REQUIREMENTS, ALLOWING IT TO BE RELEASED FOR DISTRIBUTION. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. BRONCHITIS IS A KNOWN ADVERSE EVENT NOTED IN THE DFU. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ANTICIPATED PROCEDURAL COMPLICATION.

    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) 2012 AS PART OF THE (B)(6) STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ACUTE BRONCHITIS TREATED WITH ANTIBIOTIC. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HIS FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT LOWER LOBE ON (B)(6) 2012. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED. ON (B)(6), 2012, THE PATIENT EXPERIENCED EXACERBATION OF HIS ASTHMA INCLUDING SYMPTOMS OF PRODUCTIVE COUGH AND NON-CARDIAC CHEST PAIN. NO MEDICAL INTERVENTION WAS REQUIRED. THE EVENT WAS CONSIDERED FULLY RESOLVED AS OF (B)(6) 2012. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT. ON (B)(6) 2012, THE PATIENT EXPERIENCED HEMOPTYSIS. NO MEDICAL INTERVENTION WAS REQUIRED AND THE EVENT WAS CONSIDERED RESOLVED AS OF (B)(6) 2012. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT. ON (B)(6), 2012, THE PATIENT EXPERIENCED ACUTE BRONCHITIS. THE EVENT WAS TREATED WITH A Z-PAK. THE EVENT WAS CONSIDERED RESOLVED AS OF (B)(6) 2012. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6), 2012: PRE-BRONCHODILATOR; FEV1: 2.81; FEV1 % PREDICTED: 74.34; FVC: 4.10; FVC % PREDICTED: 90.91. POST-BRONCHODILATOR: FEV1: 3.08; FEV1 % PREDICTED: 81.48; FVC: 4.52; FVC % PREDICTED: 100.22.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALAIR BRONCHIAL THERMOPLASTY CATHETER ELECTROSURGICAL, BRONCHIAL THERMOPLASTY CATHETER & SYSTEM & ACCESSORIES OOY BOSTON SCIENTIFIC - SAN JOSE M005ATS25010 CM-060112-036

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention