BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 2972799 · Received February 21, 2013

    Report

    Report Number
    3005099803-2013-01115
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    December 29, 2010
    Report Date
    January 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S BMI WAS REPORTED TO BE 24.5. (B)(4). LITERATURE SOURCE: DOEING, DIANA C., MAHAJAN, AMIT K., WHITE, STEVEN R., NAURECKAS, EDWARD T., KRISHNAN, JERRY A. AND DOUGLAS K. HOGARTH. "SAFETY AND FEASIBILITY OF BRONCHIAL THERMOPLASTY IN ASTHMA PATIENTS WITH VERY SEVERE FIXED AIRFLOW OBSTRUCTION: A CASE SERIES." JOURNAL OF ASTHMA (2012): 1-4. WEB. 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

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN EVENT DETAILED WITHIN THE LITERATURE ARTICLE "SAFETY AND FEASIBILITY OF BRONCHIAL THERMOPLASTY IN ASTHMA PATIENTS WITH VERY SEVERE FIXED AIRFLOW OBSTRUCTION: A CASE SERIES", IN WHICH AN ALAIR CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF LOWER RESPIRATORY TRACT INFECTION TREATED WITH ANTIBIOTICS. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HIS THIRD BRONCHIAL THERMOPLASTY (BT) PROCEDURE, ON (B)(6) 2010, THE PATIENT DEVELOPED MILD HEMOPTYSIS. A BRONCHOSCOPIC INSPECTION FOLLOWING THE HEMOPTYSIS DID NOT REVEAL A SOURCE OF THE BLEEDING AND THE PATIENT DID NOT REQUIRE FURTHER INTERVENTION. ON (B)(6), 2010, THE PATIENT WAS DIAGNOSED WITH A LOWER RESPIRATORY TRACT INFECTION. THE INFECTION WAS TREATED WITH AZITHROMYCIN AND MOXIFLOXACIN. THE INFECTION HAS RESOLVED. AS PER THE PROTOCOL, THE PATIENT RECEIVED PREDNISONE (50MG DAILY) FOR THREE DAYS, PRIOR TO THE DAY OF THE PROCEDURE, AT THE DAY OF THE PROCEDURE, AND ONE DAY AFTER THE BT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76569 ALAIR BRONCHIAL THERMOPLASTY CATHETER ELECTROSURGICAL, BRONCHIAL THERMOPLASTY CATHETER & SYSTEM & ACCESSORIES OOY BOSTON SCIENTIFIC - SAN JOSE M005ATS25010

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention