BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR?

    MDR report key: 3718395 · Received April 1, 2014

    Report

    Report Number
    3005099803-2014-01478
    Event Type
    Injury
    Date Received
    April 1, 2014
    Report Date
    March 4, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PATIENT'S EXACT AGE IS UNKNOWN, IT WAS REPORTED SHE IS OVER EIGHTEEN YEARS OF AGE. 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. 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. THIS REPORT IS BEING SENT AS A RESULT OF A PATIENT BEING ADMITTED TO THE HOSPITAL. THE PATIENT UNDERWENT HER THIRD BT TREATMENT (PROCEDURE DATE UNKNOWN) TO THE UPPER RIGHT AND LEFT LOBES OF THE LUNGS. THERE WERE NO PATIENT ISSUES REPORTED DURING THE PROCEDURE. THERE WAS NO DEVICE MALFUNCTION REPORTED DURING THE PROCEDURE. ABOUT A WEEK AFTER THE PROCEDURE THE PATIENT EXPERIENCED ATELECTASIS IN BOTH LUNGS AND WAS ADMITTED TO WINTHROP UNIVERSITY HOSPITAL UNDER THE CARE OF A DIFFERENT DOCTOR THAN WHO PERFORMED THE BT PROCEDURE. THE PATIENT WAS INTUBATED AND SPENT SOME TIME IN THE HOSPITAL AND WAS REPORTED TO BE DOING FINE. THE PHYSICIAN FROM WINTHROP HOSPITAL ATTRIBUTED THE ATELECTASIS TO THE BT PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUND 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
    193911 ALAIR? BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R