BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 6559495 · Received May 10, 2017

    Report

    Report Number
    3005099803-2017-01451
    Event Type
    Injury
    Date Received
    May 10, 2017
    Date of Event
    April 9, 2017
    Report Date
    May 3, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. 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) 2017. ON (B)(6) 2017, THE PATIENT UNDERWENT THE SECOND BT TREATMENT PERFORMED IN THE LEFT LOWER LOBES OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE PHYSICIAN, ON (B)(6) 2017, THE PATIENT EXPERIENCED A TYPICAL ASTHMA EXACERBATION. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS TREATED WITH STANDARD ASTHMA TREATMENT (I.E. SOLU MEDROL). ON (B)(6) 2017 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THE PATIENT¿S CURRENT CONDITION WAS REPORTED TO BE ¿FINE¿. IN THE PHYSICIAN¿S ASSESSMENT, THE PATIENT¿S ASTHMA EXACERBATION IS MOST LIKELY NOT RELATED TO THE SECOND BRONCHIAL THERMOPLASTY TREATMENT, ALTHOUGH IT IS HARD TO SAY FOR SURE. THE ASTHMA EXACERBATION COULD HAVE BEEN CAUSED BY MULTIPLE OTHER TRIGGERS RELATING TO THE PATIENT¿S MEDICAL HISTORY. ON (B)(6) 2017 THE PATIENT UNDERWENT THE THIRD BT TREATMENT SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340359 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - MARLBOROUGH M005ATS25010

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization