BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 3201328 · Received July 2, 2013

    Report

    Report Number
    3005099803-2013-06062
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 8, 2013
    Report Date
    June 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION DATE AND DEVICE MANUFACTURE DATE ARE UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST THE EXPIRATION DATE. (B)(4). A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE DFU LIST HEMOPTYSIS AS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THIS DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BT CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HIS THIRD BRONCHIAL THERMOPLASTY PROCEDURE TO THE RIGHT AND LEFT UPPER LOBES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED. ON (B)(6) 2013, THE PATIENT WAS REPORTED TO HAVE BEEN "FEELING PRETTY GOOD" AND BEGAN HEAVY PHYSICAL EXERCISE. AT THIS TIME, THE PATIENT FELT A SENSATION OF CHEST PAIN ALONG WITH A SMALL AMOUNT OF BLOOD IN THE SPUTUM. APPROXIMATELY TWO HOURS LATER, THE PATIENT EXPERIENCED SIGNIFICANT HEMOPTYSIS OF ABOUT 150ML OF BLOOD. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM WHERE HE UNDERWENT A BRONCHIAL ARTERY EMBOLIZATION. THE BLEEDING WAS DETERMINED TO BE FROM THE LEFT UPPER LOBE. FOLLOWING THE EMBOLIZATION, THE PATIENT HAS REPORTEDLY BEEN DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301520 ALAIR BRONCHIAL THERMOPLASTY CATHETER ELECTROSURGICAL, BRONCHIAL THERMOPLASTY CATHETER & SYSTEM & ACCESSORIES OOY BOSTON SCIENTIFIC - SAN JOSE M005ATS25020

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention