BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 4940207 · Received July 24, 2015

    Report

    Report Number
    3005099803-2015-02016
    Event Type
    Injury
    Date Received
    July 24, 2015
    Report Date
    June 29, 2015
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE: THE EXACT AGE OF THE PATIENT IS UNKNOWN, HOWEVER, THE PATIENT WAS REPORTED TO BE OVER 18. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HIS FIRST BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE RIGHT LOWER LOBE OF THE LUNG. THERE WERE NO REPORTED ISSUES WITH THE ALAIR BRONCHIAL THERMOPLASTY CATHETER. FOLLOWING THE PROCEDURE, THE PATIENT WAS HOSPITALIZED FOR ACUTE ASTHMA. THE PATIENT WAS RELEASED FROM THE HOSPITAL. (DISCHARGE DATE UNKNOWN). THE PHYSICIAN REPORTED THAT THE PATIENT IS CURRENTLY DOING ¿VERY WELL¿.

    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. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HIS FIRST BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE RIGHT LOWER LOBE OF THE LUNG. THERE WERE NO REPORTED ISSUES WITH THE ALAIR BRONCHIAL THERMOPLASTY CATHETER. FOLLOWING THE PROCEDURE, THE PATIENT WAS HOSPITALIZED FOR ACUTE ASTHMA. THE PATIENT WAS RELEASED FROM THE HOSPITAL. (DISCHARGE DATE UNKNOWN). THE PHYSICIAN REPORTED THAT THE PATIENT IS CURRENTLY DOING ¿VERY WELL.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483718 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization