BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 2912436 · Received January 12, 2013

    Report

    Report Number
    3005099803-2012-06249
    Event Type
    Injury
    Date Received
    January 12, 2013
    Date of Event
    March 2, 2012
    Report Date
    March 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). STUDY SOURCE: (B)(6). 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. PNEUMONIA IS A KNOWN ADVERSE EVENT NOTED IN THE DFU. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    MFR NAME: BOSTON SCIENTIFIC CORPORATION (B)(4). STUDY SOURCE: (B)(6).

    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). THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF PNEUMONIA REQUIRING HOSPITALIZATION AND TREATED WITH ANTIBIOTICS. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT AND LEFT UPPER LOBES ON (B)(6) 2012. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO MALFUNCTIONS. ON (B)(6) 2012 THE PATIENT EXPERIENCED ASTHMA EXACERBATION WHICH WAS TREATED WITH THE PATIENT'S USUAL ASTHMA RESCUE TREATMENT OF ALBUTEROL (90 MCG, 2 PUFFS/USE PRN.) THE ASTHMA AGGRAVATION WAS REPORTED TO HAVE STOPPED ON (B)(6) 2012. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT. ON (B)(6) 2012 THE PATIENT EXPERIENCED AN EVENT OF PNEUMONIA. ON (B)(6) 2012 THE PATIENT HAD SHORTNESS OF BREATH AND A PRODUCTIVE COUGH. THIS WAS TREATED WITH AUGMENTIN. ON (B)(6) 2012. THE PATIENT WENT TO THE EMERGENCY ROOM, PRESENTED WITH AN O2 SATURATION OF 86% AND SHOWED CONSOLIDATION IN THE RIGHT MIDDLE LOBE AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. ON (B)(6) 2012 THE PATIENT HAD A FOLLOW UP VISIT WITH CHEST X-RAY, WHICH REVEALED THAT THE PNEUMONIA WAS CLEARING WITH RESIDUAL INFILTRATE. ACCORDING TO THE INVESTIGATOR, THIS EVENT IS POSSIBLY RELATED TO THE PATIENT'S THIRD BT PROCEDURE DUE TO ABSENCE OF THE TYPICAL SYMPTOMS OF PNEUMONIA PRIOR TO CLINICAL DETERIORATION REQUIRING ADMISSION TO THE HOSPITAL. BASELINE SPIROMETRY VALUES, VISIT DATE: (B)(6) 2011: PRE-BRONCHODILATOR, FEV1: 1.76, FEV1 % PREDICTED: 70.12, FVC: 1.82, FVC % PREDICTED: 57.78. POST-BRONCHODILATOR: FEV1: 1.82, FEV1 % PREDICTED: 72.51, FVC: 2.87, FVC % PREDICTED: 91.11.

    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 PNEUMONIA REQUIRING HOSPITALIZATION AND TREATED WITH ANTIBIOTICS. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT AND LEFT UPPER LOBES ON (B)(6) 2012. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO MALFUNCTIONS. ON (B)(6) 2012 THE PATIENT EXPERIENCED ASTHMA EXACERBATION WHICH WAS TREATED WITH THE PATIENT'S USUAL ASTHMA RESCUE TREATMENT OF ALBUTEROL (90MCG, 2 PUFFS/USE PRN.) THE ASTHMA AGGRAVATION WAS REPORTED TO HAVE STOPPED ON (B)(6) 2012. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT. ON (B)(6) 2012 THE PATIENT EXPERIENCED AN EVENT OF PNEUMONIA. ON (B)(6) 2012 THE PATIENT HAD SHORTNESS OF BREATH AND A PRODUCTIVE COUGH. THIS WAS TREATED WITH AUGMENTIN. ON (B)(6) 2012. THE PATIENT WENT TO THE EMERGENCY ROOM, PRESENTED WITH AN O2 SATURATION OF 86% AND SHOWED CONSOLIDATION IN THE RIGHT MIDDLE LOBE AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. ON (B)(6) 2012 THE PATIENT HAD A FOLLOW UP VISIT WITH CHEST X-RAY, WHICH REVEALED THAT THE PNEUMONIA WAS CLEARING WITH RESIDUAL INFILTRATE. ACCORDING TO THE INVESTIGATOR, THIS EVENT IS POSSIBLY RELATED TO THE PATIENT'S THIRD BT PROCEDURE DUE TO ABSENCE OF THE TYPICAL SYMPTOMS OF PNEUMONIA PRIOR TO CLINICAL DETERIORATION REQUIRING ADMISSION TO THE HOSPITAL. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2011: PRE-BRONCHODILATOR; FEV1: 1.76; FEV1 % PREDICTED: 70.12; FVC: 1.82; FVC % PREDICTED: 57.78. POST-BRONCHODILATOR; FEV1: 1.82; FEV1 % PREDICTED: 72.51; FVC: 2.87; FVC % PREDICTED: 91.11. ***UPDATE (B)(6) 2013*** THE REPORTED EVENT OF PNEUMONIA RESOLVED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19265 ALAIR BRONCHIAL THERMOPLASTY CATHETER ELECTROSURGICAL, BRONCHIAL THERMOPLASTY CATHETER & SYSTEM & ACCESSORIES OOY BOSTON SCIENTIFIC - SAN JOSE M005ATS25010 052110-85

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R