BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 2471811 · Received February 29, 2012

    Report

    Report Number
    3005099803-2012-00512
    Event Type
    Injury
    Date Received
    February 29, 2012
    Date of Event
    January 20, 2012
    Report Date
    February 2, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). STUDY: (B)(4). 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2011, AS PART OF THE (B)(4) CLINICAL STUDY. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER SECOND BRONCHIAL THERMOPLASTY TREATMENT TO THE LEFT LOWER LOBE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED. THE PATIENT EXPERIENCED TWO EVENTS OF ASTHMA EXACERBATION FOLLOWING THE PROCEDURE. THE FIRST EVENT BEGAN ON (B)(6) 2011, WAS TREATED WITH AN INCREASE IN ALBUTEROL AND WAS RESOLVED ON (B)(6) 2011. THE SECOND EVENT OF ASTHMA EXACERBATION BEGAN ON (B)(6) 2012, WAS TREATED WITH A PREDNISONE BURST AND WAS RESOLVED ON (B)(6) 2012. ON (B)(6) 2012, TWENTY FOUR DAYS POST PROCEDURE, THE PATIENT EXPERIENCED AN UPPER RESPIRATORY TRACT INFECTION, WHICH WAS TREATED WITH AZITHROMYCIN. THE EVENT WAS REPORTED AS RESOLVED ON (B)(6) 2012. NO HOSPITALIZATION OR EMERGENCY ROOM VISITS OCCURRED FROM ANY OF THE EVENTS ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALAIR BRONCHIAL THERMOPLASTY CATHETER ELECTROSURGICAL, BRONCHIAL THERMOPLASTY CATHETER & SYSTEM & ACCESSORIES OOY BOSTON SCIENTIFIC - MARLBOROUGH M005ATS25010 030110-55

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention