BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 2983643 · Received February 28, 2013

    Report

    Report Number
    3005099803-2013-00928
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR NAME: BOSTON SCIENTIFIC CORPORATION (B)(4). STUDY SOURCE: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). (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. BRONCHITIS IS LISTED IN THE DIRECTIONS FOR USE (DFU) AS A POTENTIAL ADVERSE EVENT THAT MAY OCCUR. THEREFORE, AS THE REPORTED COMPLAINT 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) 2013 AS PART OF THE (B)(4) STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF BRONCHITIS TREATED WITH ANTIBIOTICS. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER SECOND BRONCHIAL THERMOPLASTY TREATMENT TO THE LEFT LOWER LOBE ON (B)(6) 2012. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED. FOLLOWING THE PROCEDURE, ON (B)(6) 2013, THE PATIENT COMPLAINED OF A SORE THROAT, WHICH WAS TREATED WITH A CEPACOL LOZENGE. THE EVENT RESOLVED ON THE SAME DAY. FOLLOWING DISCHARGE ON (B)(6), 2013, THE PATIENT COMPLAINT OF BILATERAL LOWER ANTERIOR RESPIRATORY CHEST PAIN WHEN TAKING A DEEP BREATH. NO MEDICATION INTERVENTION WAS REQUIRED FOR THIS EVENT AND THE CHEST PAIN WAS CONSIDERED RESOLVED AS OF (B)(6) 2013. ON (B)(6) 2013, THE PATIENT EXPERIENCED AN EVENT OF ACUTE BRONCHITIS WITH SYMPTOMS OF PRODUCTIVE COUGH AND YELLOW SPUTUM. ON (B)(6) 2013, THE PATIENT WENT TO URGENT CARE AND WAS PRESCRIBED ZITHROMAX AND ROBITUSSIN AC. IT WAS REPORTED THAT THE EVENT IS CONTINUING. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6), 2012: PRE-BRONCHODILATOR; FEV1: 2.27; FEV1 % PREDICTED: 88.67; FVC: 3.70; FVC % PREDICTED: 124.16. POST-BRONCHODILATOR; FEV1: 2.76; FEV1 % PREDICTED: 107.81; FVC: 3.69; FVC % PREDICTED: 123.83. **ADDITIONAL INFORMATION RECEIVED SINCE (B)(6) 2013** ACCORDING TO THE COMPLAINANT, THE EVENT OF ACUTE BRONCHITIS RESOLVED ON (B)(6) 2013. **CORRECTION** THE PATIENT VISITED URGENT CARE AND WAS PRESCRIBED ZITHROMAX AND ROBITUSSIN AC ON (B)(6) 2013 AS PREVIOUSLY REPORTED.

    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) 2013 AS PART OF THE (B)(4). THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF BRONCHITIS TREATED WITH ANTIBIOTICS. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER SECOND BRONCHIAL THERMOPLASTY TREATMENT TO THE LEFT LOWER LOBE ON (B)(6) 2012. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED. FOLLOWING THE PROCEDURE, ON (B)(6) 2013, THE PATIENT COMPLAINED OF A SORE THROAT, WHICH WAS TREATED WITH A CEPACOL LOZENGE. THE EVENT RESOLVED ON THE SAME DAY. FOLLOWING DISCHARGE ON (B)(6) 2013, THE PATIENT COMPLAINT OF BILATERAL LOWER ANTERIOR RESPIRATORY CHEST PAIN WHEN TAKING A DEEP BREATH. NO MEDICATION INTERVENTION WAS REQUIRED FOR THIS EVENT AND THE CHEST PAIN WAS CONSIDERED RESOLVED AS OF (B)(6) 2013. ON (B)(6) 2013, THE PATIENT EXPERIENCED AN EVENT OF ACUTE BRONCHITIS WITH SYMPTOMS OF PRODUCTIVE COUGH AND YELLOW SPUTUM. ON (B)(6) 2013, THE PATIENT WENT TO URGENT CARE AND WAS PRESCRIBED ZITHROMAX AND ROBITUSSIN AC. IT WAS REPORTED THAT THE EVENT IS CONTINUING. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2012. PRE-BRONCHODILATOR: FEV1: 2.27; FEV1 % PREDICTED: 88.67; FVC: 3.70; FVC % PREDICTED: 124.16. POST-BRONCHODILATOR: FEV1: 2.76; FEV1 % PREDICTED: 107.81; FVC: 3.69; FVC % PREDICTED: 123.83.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87590 ALAIR BRONCHIAL THERMOPLASTY CATHETER ELECTROSURGICAL, BRONCHIAL THERMOPLASTY CATHETER & SYSTEM & ACCESSORIES OOY BOSTON SCIENTIFIC - SAN JOSE M005ATS25010 CM-081012-017

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention