BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 6429462 · Received March 23, 2017

    Report

    Report Number
    3005099803-2017-00715
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    January 25, 2017
    Report Date
    February 27, 2017
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STUDY SOURCE: E7086 BSC BT REGISTRY. 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) 2017 AS PART OF THE E7086 BSC BT REGISTRY CLINICAL STUDY. ON (B)(6) 2017 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BT PROCEDURE. ON (B)(6) 2017 THE PATIENT UNDERWENT THE FIRST BRONCHIAL THERMOPLASTY TREATMENT PERFORMED ON THE RIGHT LOWER LOBE OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017, THE PATIENT EXPERIENCED ASTHMATIC COUGH AND MUCUS PRODUCTION ONE DAY POST PROCEDURE. THE COUGH WAS TREATED WITH SYSTEMIC CORTICOSTEROIDS (PREDNISOLONE) AND HOSPITALIZATION WAS EXTENDED DUE TO THE EVENT. THE MUCUS PRODUCTION WAS TREATED WITH MEDICATION OR REGIMEN WAS ADJUSTED, ALTHOUGH THE EXACT MEDICATION WAS NOT REPORTED (NO SYSTEMIC CORTICOSTEROID WAS ADMINISTERED). ON (B)(6) 2017 THE COUGH RESOLVED, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2017 THE MUCUS PRODUCTION RESOLVED. BASELINE SPIROMETRY VALUES: VISIT DATE (B)(6) 2017. PRE-BRONCHODILATOR: FEV1: 2.51, FEV1 % PREDICTED: 100, FVC: 2.93, FVC % PREDICTED: 99.30. POST-BRONCHODILATOR: FEV1: 2.52, FEV1 % PREDICTED: 100.10, FVC: 2.97, FVC % PREDICTED: 100.40.

    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) 2017 AS PART OF THE E7086 BSC BT REGISTRY CLINICAL STUDY. ON (B)(6) 2017 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BT PROCEDURE. ON (B)(6) 2017 THE PATIENT UNDERWENT THE FIRST BRONCHIAL THERMOPLASTY TREATMENT PERFORMED ON THE RIGHT LOWER LOBE OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017, THE PATIENT EXPERIENCED ASTHMATIC COUGH AND MUCUS PRODUCTION ONE DAY POST PROCEDURE. THE COUGH WAS TREATED WITH SYSTEMIC CORTICOSTEROIDS (PREDNISOLONE) AND HOSPITALIZATION WAS EXTENDED DUE TO THE EVENT. THE MUCUS PRODUCTION WAS TREATED WITH MEDICATION OR REGIMEN WAS ADJUSTED, ALTHOUGH THE EXACT MEDICATION WAS NOT REPORTED (NO SYSTEMIC CORTICOSTEROID WAS ADMINISTERED). ON (B)(6) 2017 THE COUGH RESOLVED, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2017 THE MUCUS PRODUCTION RESOLVED. BASELINE SPIROMETRY VALUES: VISIT DATE (B)(6) 2017: PRE-BRONCHODILATOR, FEV1: 2.51, FEV1 % PREDICTED: 100, FVC: 2.93, FVC % PREDICTED: 99.30. POST-BRONCHODILATOR, FEV1: 2.52, FEV1 % PREDICTED: 100.10, FVC: 2.97, FVC % PREDICTED: 100.40 . ADDITIONAL INFORMATION RECEIVED ON 30MAY2017: ON (B)(6) 2017 THE PATIENT EXPERIENCED BLOOD TINGED SPUTUM. NO ACTION WAS REQUIRED FOR THE EVENT, AND THE EVENT RESOLVED ON THE SAME DAY. NO HOSPITALIZATIONS OR ER VISITS OCCURRED DUE TO THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON 15JUN2017: "THE SUBJECT WAS HOSPITALIZED FROM (B)(6) FOR INPATIENT TREATMENT. SUBJECT UNDERWENT A HRCT OF THE LUNG ON (B)(6) 2017 PRIOR TO THE BT PROCEDURE WHICH REVEALED A FOCAL MASS IN THE LEFT POSTEROBASAL SEGMENT OF THE LLL, MEASURING 5MM, MOST LIKELY A MUCOID CAP. NO EVIDENCE OF CORRELATION FOR RESPIRATORY DISEASE WAS FOUND. SUBJECT WAS GIVEN AZITHROMYCIIN AS PROBATORY TREATMENT AS WELL AS THE PREDNISOLONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212187 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25020 17994933

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R