BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR?

    MDR report key: 3726033 · Received April 3, 2014

    Report

    Report Number
    3005099803-2014-01610
    Event Type
    Injury
    Date Received
    April 3, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). STUDY SOURCE: POST-FDA APPROVAL CLINICAL TRIAL EVALUATING BRONCHIAL THERMOPLASTY IN SEVERE PERSISTENT ASTHMA (B)(4). 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 LIST INFECTION (RESPIRATORY), AND 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 THAT AN ALAIR BRONCHIAL THERMOPLASTY CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY (BT) PROCEDURE ON (B)(6) 2014 AS PART OF THE (B)(4) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF UPPER RESPIRATORY TRACT INFECTION (URTI) TREATED WITH ANTIBIOTICS. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER THIRD BT TREATMENT TO THE RIGHT AND LEFT UPPER LOBES ON (B)(6) 2014. THERE WAS NO DEVICE MALFUNCTION REPORTED DURING THE PROCEDURE. ON (B)(6) 2014 THE PATIENT EXPERIENCED ASTHMA AGGRAVATION WITH THE SYMPTOMS OF COUGH AND WHEEZE. THE PATIENT WAS TREATED WITH PREDNISONE AND THE ASTHMA WAS REPORTED TO HAVE RESOLVED ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT EXPERIENCED AN UPPER RESPIRATORY TRACT INFECTION (URTI) WITH THE SYMPTOMS OF COUGH AND WHEEZE AND WAS TREATED WITH Z-PAK. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED AS A RESULT EITHER EVENT. THE EVENT OF URTI IS REPORTED AS RESOLVED AS OF (B)(6) 2014. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2013. PRE-BRONCHODILATOR: FEV1: 2.78; FEV1 % PREDICTED: 94.56; FVC: 3.24; FVC % PREDICTED: 84.60. POST-BRONCHODILATOR: FEV1: 2.93; FEV1 % PREDICTED: 99.66; FVC: 3.28; FVC % PREDICTED: 85.64.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201617 ALAIR? BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010 CM-112712-039

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention