BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 3212833 · Received July 9, 2013

    Report

    Report Number
    3005099803-2013-06067
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    April 29, 2013
    Report Date
    June 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL SPECIFICATION REQUIREMENTS, ALLOWING IT TO BE RELEASED FOR DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. 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 PNEUMONIA AS A POSSIBLE ADVERSE EVENT ASSOCIATED 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 BT CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2012 AS PART OF THE (B)(4). ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HIS THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT AND LEFT UPPER LOBES ON (B)(6) 2012. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED AN EVENT OF PNEUMONIA WITH THE SYMPTOMS OF FEVER, COUGH, AND NAUSEA. ON (B)(6) 2013, THE PATIENT WENT TO THE EMERGENCY ROOM (ER) FOR FEVER AND TESTICULAR PAIN. IN ADDITION, THE PATIENT COMPLAINED OF EAR PAIN BILATERALLY AND A SORE THROAT. A CHEST X-RAY WAS PERFORMED AND SHOWED LEFT LOWER LOBE (LLL) INFILTRATES. THE PATIENT WAS DIAGNOSED WITH PNEUMONIA AND WAS TREATED WITH CIPROFLOXACIN, KETOROLAC (TORADOL), AND LEVOFLOXACIN (LEVAQUIN). NO HOSPITALIZATIONS OCCURRED AS A RESULT OF THIS EVENT. THE EVENT WAS CONSIDERED RESOLVED AS OF (B)(6) 2013. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2012. PRE-BRONCHODILATOR: FEV1: 3.42; FEV1 % PREDICTED: 88.14; FVC: 4.53; FVC % PREDICTED: 92.45. POST-BRONCHODILATOR: FEV1: 3.58; FEV1 % PREDICTED: 92.27; FVC: 4.73; FVC % PREDICTED: 96.53.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314427 ALAIR BRONCHIAL THERMOPLASTY CATHETER ELECTROSURGICAL, BRONCHIAL THERMOPLASTY CATHETER & SYSTEM & ACCESSORIES OOY BOSTON SCIENTIFIC - SAN JOSE M005ATS25010 CM-051412-030

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention