BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 4964157 · Received August 4, 2015

    Report

    Report Number
    3005099803-2015-02123
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    June 16, 2015
    Report Date
    July 9, 2015
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. STUDY SOURCE: (B)(4) CLINICAL STUDY. 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 CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2015 AS PART OF THE (B)(4) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF BRONCHITIS TREATED WITH MEDICATION. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2015, THE PATIENT UNDERWENT THE FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT LOWER LOBE OF THE LUNGS. THERE WERE NO ISSUES REPORTED TO THE DEVICE. ON (B)(6) 2015, THE PATIENT EXPERIENCED BRONCHITIS. NO EMERGENCY ROOM VISITS OCCURRED, HOWEVER, THE PATIENT WAS HOSPITALIZED ON (B)(6) 2015, FOR BRONCHITIS AND WAS TREATED WITH MEDICATION (EXACT MEDICATION ADMINISTERED WAS NOT REPORTED). ON (B)(6) 2015, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE EVENT WAS CONSIDERED TO BE RESOLVED AS OF (B)(6) 2015, AND THE PATIENT WAS REPORTED TO BE RECOVERING.

    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) 2015 AS PART OF THE (B)(6) STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF BRONCHITIS TREATED WITH MEDICATION. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2015, THE PATIENT UNDERWENT THE FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT LOWER LOBE OF THE LUNGS. THERE WERE NO ISSUES REPORTED TO THE DEVICE. ON (B)(6) 2015, THE PATIENT EXPERIENCED BRONCHITIS. NO EMERGENCY ROOM VISITS OCCURRED, HOWEVER, THE PATIENT WAS HOSPITALIZED ON (B)(6) 2015, FOR BRONCHITIS AND WAS TREATED WITH MEDICATION (EXACT MEDICATION ADMINISTERED WAS NOT REPORTED). ON (B)(6) 2015, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE EVENT WAS CONSIDERED TO BE RESOLVED AS OF (B)(6) 2015, AND THE PATIENT WAS REPORTED TO BE RECOVERING. ADDITIONAL INFORMATION RECEIVED ON 18NOV2016. BASELINE SPIROMETRY VALUES. VISIT DATE: (B)(6) 2015. PRE-BRONCHODILATOR. FEV1: 00.77. FEV1 % PREDICTED: 45.00. FVC: 01.35. FVC % PREDICTED: 56.00. POST-BRONCHODILATOR. FEV1: 00.86. FEV1 % PREDICTED: 51.00. FVC: 01.46. FVC % PREDICTED: 61.00.

    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) 2015 AS PART OF THE (B)(6) STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF BRONCHITIS TREATED WITH MEDICATION. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2015, THE PATIENT UNDERWENT THE FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT LOWER LOBE OF THE LUNGS. THERE WERE NO ISSUES REPORTED TO THE DEVICE. ON (B)(6) 2015, THE PATIENT EXPERIENCED BRONCHITIS. NO EMERGENCY ROOM VISITS OCCURRED, HOWEVER, THE PATIENT WAS HOSPITALIZED ON (B)(6) 2015, FOR BRONCHITIS AND WAS TREATED WITH MEDICATION (EXACT MEDICATION ADMINISTERED WAS NOT REPORTED). ON (B)(6) 2015, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE EVENT WAS CONSIDERED TO BE RESOLVED AS OF (B)(6) 2015, AND THE PATIENT WAS REPORTED TO BE RECOVERING. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2016; BASELINE SPIROMETRY VALUES; VISIT DATE: (B)(6) 2015. PRE-BRONCHODILATOR: FEV1: 00.77, FEV1 % PREDICTED: 45.00, FVC: 01.35, FVC % PREDICTED: 56.00. POST-BRONCHODILATOR: FEV1: 00.86, FEV1 % PREDICTED: 51.00, FVC: 01.46, FVC % PREDICTED: 61.00. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2016. FOLLOWING THE FIRST BRONCHIAL THERMOPLASTY PROCEDURE, THE PATIENT WAS HOSPITALIZED FOR OBSERVATION ONLY. ON (B)(6) 2015, THE PATIENT EXPERIENCED BRONCHITIS. MEDICATION WAS GIVEN OR REGIMEN WAS ADJUSTED TO TREAT THE BRONCHITIS (EXACT MEDICATION NOT REPORTED). THERE WAS NO HOSPITALIZATION ASSOCIATED WITH THIS EVENT. VISIT DATE ASSOCIATED WITH BASELINE SPIROMETRY VALUES UPDATED TO (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508224 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25020 17336483

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R