BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 3203035 · Received July 2, 2013

    Report

    Report Number
    3005099803-2013-05956
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR NAME: BOSTON SCIENTIFIC CORPORATION (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 MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO 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. MUCOUS PLUG AND WHEEZING ARE LISTED IN THE DFU AS POTENTIAL ADVERSE EVENTS THAT MAY OCCUR. 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) 2013. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER THIRD BRONCHIAL THERMOPLASTY PROCEDURE TO THE RIGHT AND LEFT UPPER LOBES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT EXPERIENCED ONLY A LIGHT SECRETION DURING IRRIGATION. NO TECHNICAL PROBLEMS WERE ENCOUNTERED. ON (B)(6) 2013, THE PATIENT RETURNED FOR A FOLLOW-UP VISIT AND THE PHYSICIAN NOTED SOME WHEEZING AND A LIGHT LOWER SATURATION. ON (B)(6) 2013, THE PATIENT UNDERWENT A BRONCHOSCOPY AND A PLUG OF "HIGHLY VISCOUS FIBRINOGENOUS MUCOUS" WAS FOUND. THE PHYSICIAN USED FORCEPS TO LIGHTLY PULL AND REMOVE THE MUCOUS PLUG FROM THE PATIENT. THE PATIENT'S STATUS IMPROVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302011 ALAIR BRONCHIAL THERMOPLASTY CATHETER ELECTROSURGICAL, BRONCHIAL THERMOPLASTY CATHETER & SYSTEM & ACCESSORIES OOY BOSTON SCIENTIFIC - SAN JOSE M005ATS25020 CM062212

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R