BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 4838820 · Received June 11, 2015

    Report

    Report Number
    3005099803-2015-01598
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    November 26, 2014
    Report Date
    May 14, 2015
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFECTION IS BEING USE TO CAPTURE THE EVENT OF INFILTRATE TREATED WITH MEDICATION. ATTEMPTS TO GET CLARIFICATION REGARDING THIS REPORT HAVE NOT BEEN SUCCESSFUL TO DATE. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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.

    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 ON (B)(6) 2014 AS PART OF THE BSC BT REGISTRY CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF LUNG INFILTRATE TREATED WITH MEDICATION. ON (B)(6) 2015, THE PATIENT UNDERWENT THE FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT LOWER LOBE OF THE LUNG. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE A LUNG INFILTRATE AND WAS HOSPITALIZED. THE HOSPITALIZATION WAS FOR OBSERVATION, HOWEVER, INTERVENTION (MEDICATION) WAS REQUIRED TO TREAT THE LUNG INFILTRATE. THE MEDICATION PROVIDED TO TREAT THE LUNG INFILTRATE WAS NOT REPORTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON NOVEMBER 27, 2014. THE EVENT IS CONSIDERED TO BE RESOLVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 ON (B)(6) 2014 AS PART OF THE (B)(4) STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF LUNG INFILTRATE TREATED WITH MEDICATION. ON (B)(6) 2015, THE PATIENT UNDERWENT THE FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT LOWER LOBE OF THE LUNG. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE A LUNG INFILTRATE AND WAS HOSPITALIZED. THE HOSPITALIZATION WAS FOR OBSERVATION, HOWEVER, INTERVENTION (MEDICATION) WAS REQUIRED TO TREAT THE LUNG INFILTRATE. THE MEDICATION PROVIDED TO TREAT THE LUNG INFILTRATE WAS NOT REPORTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. THE EVENT IS CONSIDERED TO BE RESOLVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ON (B)(6) 2014, THE PATIENT UNDERWENT THE FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT LOWER LOBE OF THE LUNG. NO ISSUES WERE NOTED WITH THE DEVICE. THE HOSPITALIZATION WAS FOR OBSERVATION AND NO MEDICATION WAS ADMINISTERED TO TREAT THE LUNG INFILTRATE. THE CAUSE OF THE LUNG INFILTRATE HAS NOT BEEN IDENTIFIED. BASELINE SPIROMETRY VALUES. POST-BRONCHODILATOR. FEV1: 1.32. FEV1 % PREDICTED: 69.00. FVC: 2.12. FVC % 82.00.

    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 ON (B)(6 2014 AS PART OF THE BSC BT REGISTRY CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF LUNG INFILTRATE TREATED WITH MEDICATION. ON (B)(6) 2015, THE PATIENT UNDERWENT THE FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT LOWER LOBE OF THE LUNG. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE A LUNG INFILTRATE AND WAS HOSPITALIZED. THE HOSPITALIZATION WAS FOR OBSERVATION, HOWEVER, INTERVENTION (MEDICATION) WAS REQUIRED TO TREAT THE LUNG INFILTRATE. THE MEDICATION PROVIDED TO TREAT THE LUNG INFILTRATE WAS NOT REPORTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. THE EVENT IS CONSIDERED TO BE RESOLVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION TO EVENT DESCRIPTION: ON (B)(6) 2014, THE PATIENT UNDERWENT THE FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT LOWER LOBE OF THE LUNG. NO ISSUES WERE NOTED WITH THE DEVICE. ADDITIONAL INFORMATION RECEIVED. BSC AWARE DATE: 08FEB2016. THE HOSPITALIZATION WAS FOR OBSERVATION AND NO MEDICATION WAS ADMINISTERED TO TREAT THE LUNG INFILTRATE. THE CAUSE OF THE LUNG INFILTRATE HAS NOT BEEN IDENTIFIED. BASELINE SPIROMETRY VALUES. POST-BRONCHODILATOR. FEV1: 1.32. FEV1 % PREDICTED: 69.00. FVC: 2.12. FVC % 82.00. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 6, 2018. POLYPOID LESION DETECTED AT ENTRANCE OF SEGMENT 6, WHICH WAS BIOPSIED. PULMONARY ASPIRATION CYTOLOGY AND MICRO PULMONARY ASPIRATION WERE PERFORMED. RESULTS PENDING. THE PATIENT WAS TREATED WITH URBASON AND LEVOFLOXACINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382585 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25020 16894336

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention