BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR?

    MDR report key: 4214093 · Received October 30, 2014

    Report

    Report Number
    3005099803-2014-03507
    Event Type
    Injury
    Date Received
    October 30, 2014
    Report Date
    August 24, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DI: (B)(4). : THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. 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 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 DATE UNKNOWN. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT LOWER LOBE. THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA AND LASTED LESS THAN 1 HOUR THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED HOME THE SAME DAY. TWENTY-FOUR HOURS POST PROCEDURE THE PATIENT DEVELOPED SIGNIFICANT BRONCHOSPASMS. THE PATIENT WAS HOSPITALIZED. FORTY EIGHT HOURS POST PROCEDURE THE PATIENT DEVELOPED SIGNIFICANT BRONCHOSPASMS. THE PATIENT NOTICED IMPROVEMENT ONE WEEK AFTER SHE WAS DISCHARGED HOME. ACCORDING TO THE PHYSICIAN, THE PATIENT HAS NOT VISITED THE ER NOR HAD AN ASTHMA EXACERBATION OVER LAST 5 MONTHS. HAS NOT USED ORAL STEROIDS AND REDUCED THE USE OF SABA'S OVER LAST 5 MONTHS. 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 WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695552 ALAIR? BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization