BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 6899188 · Received September 27, 2017

    Report

    Report Number
    3005099803-2017-02800
    Event Type
    Injury
    Date Received
    September 27, 2017
    Date of Event
    July 19, 2017
    Report Date
    August 30, 2017
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    OOY
    UDI-DI
    08714729802792
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT AGE OF THE PATIENT WAS NOT REPORTED, HOWEVER, THE PATIENT WAS OVER THE AGE OF 18 YEARS OLD. 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. (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 PERFORMED ON (B)(6) 2017. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF 'BLOOD SPUTUM' REQUIRING MEDICATION TO TREAT. ON (B)(6) 2017 THE PATIENT UNDERWENT THE FIRST BRONCHIAL THERMOPLASTY TREATMENT PERFORMED IN THE RIGHT LOWER LOBE OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017 THE PATENT EXPERIENCED BLOOD SPUTUM, REQUIRING TREATMENT WITH A HEMOSTATIC AGENT (TRANSAMIN ORAL ADMINISTRATION). ON (B)(6) 2017 THE BLOOD SPUTUM RESOLVED. ON (B)(6) 2017, DURING THE PATIENT'S SECOND BT PROCEDURE, THE PHYSICIAN EXAMINED THE PATIENT'S RIGHT LOWER LOBE IN AN ATTEMPT TO IDENTIFY THE SOURCE OF THE BLOOD SPUTUM. THE PHYSICIAN NOTED THAT THERE WAS A SLIGHT REDNESS ON THE BRONCHIAL MUCOSA (FLARE REACTION), BUT WAS UNABLE TO CONFIRM BLEEDING IN THE RIGHT LOWER LOBE. MFR REPORT# 3005099803-2017-02800 CREATED FOR ADVERSE EVENTS RELATED TO BT PROCEDURE 1 PERFORMED ON (B)(6) 2017. MFR REPORT# 3005099803-2017-02799 CREATED FOR ADVERSE EVENTS RELATED TO BT PROCEDURE 2 PERFORMED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676740 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - COSTA RICA (COYOL) M005ATS25010 08714729802792

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention