BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 2842540 · Received November 21, 2012

    Report

    Report Number
    3005099803-2012-05539
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 29, 2012
    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

    (B)(6). MFR NAME: BOSTON SCIENTIFIC CORPORATION (B)(4). STUDY SOURCE: (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED

    Additional Manufacturer Narrative · 1

    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. UPPER RESPIRATORY TRACT INFECTION (URTI) IS A KNOWN ADVERSE EVENT LISTED 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)(4) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF UPPER RESPIRATORY TRACT INFECTION TREATED WITH ANTIBIOTIC. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE LEFT AND RIGHT UPPER LOBES ON (B)(6) 2012. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED AN EVENT OF RIGHT JAW PAIN. THE PATIENT EXPERIENCED RIGHT JAW PAIN FOLLOWING NEBULIZERS AND PFTS. THE PATIENT WAS PRESCRIBED PAIN MEDICATION; HOWEVER, THE PATIENT DID NOT TAKE THE MEDICATION AS THE EVENT HAD ALREADY RESOLVED. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT. ON (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH AN UPPER RESPIRATORY TRACT INFECTION (URTI). THE URTI WAS TREATED WITH AZITHROMYCIN (ZITHROMAX) 500MG ONCE A DAY FROM (B)(6) 2012 TO (B)(6), 2012. 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): PRE-BRONCHODILATOR, FEV1: 2.37, FEV1 % PREDICTED: 91.15, FVC: 2.68, FVC % PREDICTED: 79.76; POST-BRONCHODILATOR, FEV1: 2.47, FEV1 % PREDICTED: 95, FVC: 2.77, FVC % PREDICTED: 82.44. **ADDITIONAL INFORMATION RECEIVED SINCE (B)(6) 2013** ACCORDING TO THE COMPLAINANT, THE EVENT START DATE OF THE UPPER RESPIRATORY TRACT INFECTION (URTI) WAS (B)(6) 2012 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) 2012 AS PART OF THE POST APPROVAL 2 (PAS2) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF UPPER RESPIRATORY TRACT INFECTION TREATED WITH ANTIBIOTIC. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE LEFT AND RIGHT UPPER LOBES ON (B)(6) 2012. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED AN EVENT OF RIGHT JAW PAIN. THE PATIENT EXPERIENCED RIGHT JAW PAIN FOLLOWING NEBULIZERS AND PFTS. THE PATIENT WAS PRESCRIBED PAIN MEDICATION; HOWEVER, THE PATIENT DID NOT TAKE THE MEDICATION AS THE EVENT HAD ALREADY RESOLVED. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT. ON (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH AN UPPER RESPIRATORY TRACT INFECTION (URTI). THE URTI WAS TREATED WITH AZITHROMYCIN (ZITHROMAX) 500MG ONCE A DAY FROM (B)(6) 2012. 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: 2.37; FEV1 % PREDICTED: 91.15; FVC: 2.68; FVC % PREDICTED: 79.76. POST-BRONCHODILATOR: FEV1: 2.47 FEV1 % PREDICTED: 95; FVC: 2.77; FVC % PREDICTED: 82.44.

    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-061812-016

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention