BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR?

    MDR report key: 3734652 · Received April 8, 2014

    Report

    Report Number
    3005099803-2014-01693
    Event Type
    Injury
    Date Received
    April 8, 2014
    Date of Event
    June 25, 2013
    Report Date
    March 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    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 INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2014 THAT AN ALAIR BRONCHIAL THERMOPLASTY CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY (BT) PROCEDURE. THE REPORT IS BEING SENT AS A RESULT OF THE PATIENT BEING ADMITTED TO THE HOSPITAL AND TREATED. THE PATIENT UNDERWENT HER THIRD BT PROCEDURE TO THE UPPER RIGHT AND LEFT LOBES OF THE LUNGS ON (B)(6) 2013. THERE WAS NO DEVICE MALFUNCTION REPORTED DURING THE PROCEDURE. ON (B)(6) 2013 THE HEMOPTYSIS APPEARED DESCRIBED AS ¿RED BLOOD SPITS (2 SOUP SPOONS PER DAY)¿ AND THE PATIENT EXPERIENCED ¿PAIN AT THE LEVEL OF UPPER RIGHT LOBE¿. THE PATIENT WAS HOSPITALIZED AND A BRONCHIAL FIBERSCOPY WAS PERFORMED TO TREAT THE PATIENT BECAUSE OF ¿DISCRETE HEMORRHAGIC SUFFUSION OF THE LEFT MAIN BRONCHUS AND MUCOSA FRAGILITY AREA AT THE LEVEL OF THE RIGHT MAIN BRONCHUS¿. ACCORDING TO THE COMPLAINANT ¿THE PATIENT HEALED ON (B)(6) 2013 BUT STILL HAD BLOOD SPITS¿ AND WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210609 ALAIR? BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25020 CM081512

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R