BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 4859153 · Received June 22, 2015

    Report

    Report Number
    3005099803-2015-01707
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    February 21, 2015
    Report Date
    May 26, 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). (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 CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2015 AS PART OF THE (B)(4) STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF PROLONGED HOSPITALIZATION DUE TO ATELECTASIS TREATED WITH MEDICATION ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HIS SECOND BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2015. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED TO THE DEVICE. THE PATIENT REMAINED IN THE HOSPITAL FOR A PLANNED OVERNIGHT HOSPITAL STAY, PER HOSPITAL STANDARD OF CARE FOLLOWING A BT PROCEDURE. ON (B)(6) 2015, THE PATIENT DEVELOPED ATELECTASIS AND THE HOSPITALIZATION WAS EXTENDED. THE PATIENT WAS TREATED WITH MEDICATION (MEDICATION NAME NOT REPORTED). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. THE ATELECTASIS RESOLVED ON (B)(6) 2015. 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 CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2015 AS PART OF THE BSC BT REGISTRY CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF PROLONGED HOSPITALIZATION DUE TO ATELECTASIS TREATED WITH MEDICATION ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HIS SECOND BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2015. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED TO THE DEVICE. THE PATIENT REMAINED IN THE HOSPITAL FOR A PLANNED OVERNIGHT HOSPITAL STAY, PER HOSPITAL STANDARD OF CARE FOLLOWING A BT PROCEDURE. ON (B)(6) 2015, THE PATIENT DEVELOPED ATELECTASIS AND THE HOSPITALIZATION WAS EXTENDED. THE PATIENT WAS TREATED WITH MEDICATION (MEDICATION NAME NOT REPORTED). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. THE ATELECTASIS RESOLVED ON (B)(6) 2015. 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. ADDITIONAL INFORMATION RECEIVED ON 02SEP2015. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2015 FOR PLANNED OBSERVATION. DURING THIS OBSERVATIONAL PERIOD, THE PATIENT DEVELOPED ATELECTASIS, HOWEVER, NO TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402370 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25020 17441872

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization