BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR?

    MDR report key: 3735287 · Received April 9, 2014

    Report

    Report Number
    3005099803-2014-01697
    Event Type
    Injury
    Date Received
    April 9, 2014
    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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PATIENT¿S EXACT AGE IS UNKNOWN, IT WAS REPORTED THAT SHE WAS OVER 18 YEARS OF AGE. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRATION DATE. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND 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 BASED ON THE EVENT OF PNEUMONIA, BEING HOSPITALIZED, AND TREATED WITH A BRONCHOSCOPY TO REMOVE FLUID FROM THE PATIENT¿S RIGHT LOWER LOBE. ACCORDING TO THE COMPLAINANT, THE PATIENT DEVELOPED PNEUMONIA IN HER RIGHT LOWER LOBE ABOUT 2 WEEKS AFTER HER FIRST BT TREATMENT. SHE WENT TO THE PHYSICIAN¿S OFFICE PRESENTING WITH SYMPTOMS SO HE ORDERED AN X-RAY, WHICH INDICATED SHE HAD PNEUMONIA. HE PERFORMED A BRONCHOSCOPY AND REMOVED FLUID FROM HER RIGHT LOWER LOBE. THE PATIENT ¿IS NOW OK¿. 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 (SUPPLEMENTAL MEDWATCH REPORT) WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213637 ALAIR? BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R