BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 6863286 · Received September 13, 2017

    Report

    Report Number
    3005099803-2017-02689
    Event Type
    Injury
    Date Received
    September 13, 2017
    Date of Event
    February 15, 2016
    Report Date
    August 18, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(6). THE COMPLAINANT INDICATED THAT THE DEVICE WAS 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 (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2016. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ASTHMA EXACERBATION REQUIRING MEDICATION TO TREAT (EXACT TYPE NOT REPORTED). ON (B)(6) 2016 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BT PROCEDURE. ON (B)(6) 2016 THE PATIENT UNDERWENT THE THIRD BT PROCEDURE PERFORMED IN THE RIGHT AND LEFT UPPER LOBES OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2016 THE PATIENT DEVELOPED PERIBRONCHIAL INFLAMMATION WHICH REQUIRED NO TREATMENT. ON (B)(6) 2016 THE PERIBRONCHIAL INFLAMMATION WAS RESOLVED. ON (B)(6) 2016 THE PATIENT EXPERIENCED ASTHMA EXACERBATION AND WAS GIVEN SYSTEMIC STEROIDS FOR TREATMENT, ALONG WITH THE ADMINISTRATION OR INCREASE OF A DRUG (EXCLUDING SYSTEMIC STEROIDS), ALTHOUGH THE EXACT TYPE OF DRUG WAS NOT REPORTED. ON (B)(6) 2016 THE ASTHMA EXACERBATION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642194 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - MARLBOROUGH M005ATS25010

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention