BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR?

    MDR report key: 3728326 · Received April 4, 2014

    Report

    Report Number
    3005099803-2014-01667
    Event Type
    Injury
    Date Received
    April 4, 2014
    Date of Event
    June 24, 2013
    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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED AS THE DEVICE WAS DISPOSED AND NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE DFU LISTS ASTHMA EXACERBATION AS POSSIBLE ADVERSE EVENTS THAT MAY OCCUR WITH THE USE OF THIS DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ANTICIPATED PROCEDURAL COMPLICATION.

    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 SUBMITTED BASED ON THE EVENT OF ASTHMA EXACERBATION TREATED WITH ANTIBIOTICS AND BECAUSE THE PATIENT WAS HOSPITALIZED. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT LOWER LOBE ON (B)(6) 2013. THERE WAS NO DEVICE MALFUNCTION REPORTED DURING THE PROCEDURE. ON (B)(6) 2013, THE PATIENT DEVELOPED ASTHMA EXACERBATION. THE PHYSICIAN REPORTED THE EVENT AND STATED THAT IT WAS ¿NOT LINKED TO THE ALAIR PRODUCT.¿ THE PATIENT WAS HOSPITALIZED ON (B)(6) 2013 AND WAS TREATED WITH AUGMENTIN AND SALBUTAMOL. THE EVENT RESOLVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2013 "WITHOUT AFTEREFFECTS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204053 ALAIR? BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25020 CM081512

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R