BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 6202592 · Received December 23, 2016

    Report

    Report Number
    3005099803-2016-04029
    Event Type
    Injury
    Date Received
    December 23, 2016
    Date of Event
    May 30, 2012
    Report Date
    November 30, 2016
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT NUMBER (LOT # 072710-33) COULD NOT BE MATCHED TO THE REPORTED DEVICE. THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN AT THIS TIME. (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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2012 AS PART OF THE (B)(6) CLINICAL STUDY. ON (B)(6) 2012 THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT AND LEFT UPPER LOBES OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2012 THE PATIENT DEVELOPED A BRONCHOCELE FOLLOWING THE THIRD BT PROCEDURE. A CHEST X-RAY IN THE YEAR FOLLOWING THE PROCEDURE IS NOT AVAILABLE, HOWEVER, THERE WAS NO PARENCHYMAL LESION ON THE CT-SCAN BEFORE THE PROCEDURE. NO TREATMENT WAS NEEDED FOR THE BRONCHOCELE, AND THE EVENT IS REPORTED TO BE 'CONTINUING'. ON (B)(6) 2012 THE PATIENT EXPERIENCED AGGRAVATED ASTHMA WITH SYMPTOMS OF COUGH AND WAS TREATED WITH ICS (BECLOMETHASONE) QVAR 100MCG QD. THE AGGRAVATED ASTHMA RESOLVED ON (B)(6) 2012. NO HOSPITALIZATIONS OF EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT. IN (B)(6) 2014, THE PATIENT WAS SEEN BY THE PHYSICIAN AND REPORTED EXPERIENCING PROGRESSIVE INCREASED DYSPNEA WITH INCREASED SPUTUM BEGINNING IN THE FALL OF 2013. A CHEST X-RAY WAS PERFORMED, REVEALING A SMALL BRONCHOCELE (12 X 12.5 MM) IN THE LEFT UPPER LOBE, AND WAS CONFIRMED BY CT SCAN TO HAVE 'TREE-IN-BUD' OPACITIES AT ITS PERIPHERY. BRONCHOSCOPY WAS PERFORMED AND REVEALED THE PRESENCE OF MYCOBACTERIUM AVIUM. IN (B)(6) 2014, AN INFECTION SPECIALIST RECOMMENDED ETHAMBUTOL, RIFAMPICIN, AND CLARITHROMYCIN FOR TREATMENT. IN (B)(6) 2014, THE PATIENT'S DYSPNEA HAD IMPROVED AND THE SPUTUM WAS DECREASED. THERE WERE NO CHANGES NOTED ON THE PATIENT'S X-RAY AT THIS TIME. IN (B)(6) 2014, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE WITH NO CHANGES NOTED ON THE PATIENT'S X-RAY. IN (B)(6) 2015, THE ANTIBIOTICS WERE STOPPED AND WERE CHANGED TO AZITHROMYCIN. IN (B)(6) 2015, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE, AND THE PATIENT'S CHEST X-RAY REVEALED THAT THE WALL OF THE BRONCHOCELE APPEARS SLIGHTLY THICKENED. IN (B)(6) 2015, THE AZITHROMYCIN WAS STOPPED, AND THERE WAS NO CHANGE NOTED ON THE PATIENT'S CHEST X-RAY. IN (B)(6) 2016, THERE WAS NO CHANGE NOTED TO THE PATIENT'S CHEST X-RAY. A PET (POSITRON EMISSION TOMOGRAPHY) SCAN WAS PERFORMED: THE LESION IS COMPATIBLE WITH AN ASPERGILLOMA BUT A LOW GRADE NEOPLASM COULD NOT BE ELIMINATED. IN (B)(6) 2016, THE PATIENT UNDERWENT A RESECTION OF A SEGMENT OF THE LEFT UPPER LOBE. THE PATIENT'S HISTOPATHOLOGY CONFIRMED ASPERGILLOMA AND AN ABSENCE OF NEOPLASM. A CULTURE TEST CONFIRMED THE PRESENCE OF MYCOBACTERIUM AVIUM COMPLEX AND ASPERGILLUS FUMIGATUS. ACCORDING TO THE PHYSICIAN, SINCE THEN, THE PATIENT HAS BEEN DOING WELL. ADDITIONALLY, THE PHYSICIAN REPORTED THAT IT WAS POSSIBLE THAT THE BRONCHOCELE NOTED IN (B)(6) 2014 COULD HAVE BEEN INDUCED BY THE THIRD BRONCHIAL THERMOPLASTY TREATMENT, AND THIS BRONCHOCELE BECAME INFECTED BY MYCOBACTERIUM AVIUM AND THEREAFTER BY ASPERGILLUS. THE PHYSICIAN ALSO REPORTED A SECOND POSSIBILITY, SUGGESTING THAT THE BRONCHOCELE WAS DUE TO THE MYCOBACTERIUM AVIUM INFECTION, SINCE THE BRONCHOCELE WAS DOCUMENTED WHEN THE PATIENT COMPLAINED OF DYSPNEA AND INCREASED SPUTUM AND THE BRONCHOSCOPY DOCUMENTED THE PRESENCE OF MYCOBACTERIUM. SINCE MYCOBACTERIUM AVIUM COMPLEX INFECTIONS ARE ASSOCIATED WITH THIN WALL CAVITIES, THAT SUCH AN INFECTION WAS DOCUMENTED AT THE TIME THE PATIENT COMPLAINED OF DYSPNEA AND INCREASED SPUTUM, THE PHYSICIAN FAVORS THE MYCOBACTERIUM AVIUM INFECTION AS FIRST HYPOTHESIS FOR THE CAUSE OF THE BRONCHOCELE. IN BOTH CASES (BT INDUCED BRONCHOCELE OR MYCOBACTERIUM ASSOCIATED BRONCHOCELE), THE ASPERGILLUS THAT WAS DOCUMENTED ON THE HISTOLOGICAL SPECIMEN VERY LIKELY CAME AFTER ON A PRE-EXISTING BRONCHOCELE. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2012. PRE-BRONCHODILATOR: FEV1: 2.50, FEV1 % PREDICTED: 64.94, FVC: 4.08, FVC % PREDICTED: 83.61. POST-BRONCHODILATOR: FEV1: 2.77, FEV1 % PREDICTED: 71.95, FVC: 4.45, FVC % PREDICTED: 91.19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852582 ALAIR BRONCHIAL THERMOPLASTY CATHETER ELECTROSURGICAL, BRONCHIAL THERMOPLASTY CATHETER & SYSTEM & ACCESSORIES OOY BOSTON SCIENTIFIC - SAN JOSE M005ATS25010

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention