BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 2941919 · Received February 4, 2013

    Report

    Report Number
    3005099803-2013-00471
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    December 24, 2012
    Report Date
    January 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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 SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED IN ACCORDANCE WITH THE LABELING. PNEUMONIA IS LISTED IN THE DIRECTIONS FOR USE (DFU) AS A POTENTIAL ADVERSE EVENT THAT MAY OCCUR. THEREFORE, AS THE REPORTED EVENT IS A KNOWN POSSIBLE ADVERSE EVENT, 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)(4) STUDY. 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 CALLED THE CLINIC EXPERIENCING WHEEZING, TEMPERATURE, AND PRODUCTIVE COUGH. A CHEST X-RAY WAS PERFORMED AND REVEALED RIGHT LOWER LOBE PNEUMONIA. THE PNEUMONIA WAS TREATED WITH PREDNISONE AND ANTIBIOTIC. THE EVENT WAS CONSIDERED RESOLVED AS OF (B)(6) 2013. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2012. PRE-BRONCHODILATOR, FEV1: 2.43, FEV1 % PREDICTED: 71.47, FVC: 3.50, FVC % PREDICTED: 78.12; POST-BRONCHODILATOR, FEV1: 2.49, FEV1 % PREDICTED: 73.24, FVC: 3.89, FVC % PREDICTED: 86.83.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46308 ALAIR BRONCHIAL THERMOPLASTY CATHETER ELECTROSURGICAL, BRONCHIAL THERMOPLASTY CATHETER & SYSTEM & ACCESSORIES OOY BOSTON SCIENTIFIC - SAN JOSE M005ATS25010 CM-060112-026

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention