BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 2800187 · Received October 22, 2012

    Report

    Report Number
    3005099803-2012-04838
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    October 4, 2010
    Report Date
    September 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE BATCH/SERIAL NUMBER; THEREFORE, THE DEVICE EXPIRATION DATE AND DEVICE MANUFACTURE DATE ARE UNKNOWN. (B)(4). LITERATURE: "BRONCHIAL THERMOPLASTY: THERAPEUTIC SUCCESS IN SEVERE ASTHMA ASSOCIATED WITH PERSISTENT AIRFLOW OBSTRUCTION." JOURNAL OF ASTHMA, 2012, EARLY ONLINE: 1-3. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN 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

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN ALAIR BRONCHIAL THERMOPLASTY CATHETER THAT WAS USED TO TREAT A PATIENT FOR SEVERE PERSISTENT ASTHMA AND REPORTED WITHIN THE LITERATURE ARTICLE: "BRONCHIAL THERMOPLASTY: THERAPEUTIC SUCCESS IN SEVERE ASTHMA ASSOCIATED WITH PERSISTENT AIRFLOW OBSTRUCTION." JOURNAL OF ASTHMA, 2012, EARLY ONLINE: 1-3. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2010, THE PATIENT UNDERWENT HER THIRD BRONCHIAL THERMOPLASTY (BT) TREATMENT TO THE RIGHT AND LEFT UPPER LOBES. THE PROCEDURE INVOLVED 41 TISSUE ACTUATIONS AND WAS SUCCESSFULLY COMPLETED. NO ISSUES WERE NOTED WITH THE DEVICE. THIS COMPLAINT IS BEING REPORTED BASED ON AN EVENT OF ASTHMA EXACERBATION REQUIRING HOSPITALIZATION. FOLLOWING BT TREATMENT, THE PATIENT COMPLAINED OF DYSPNEA WITH ASSOCIATED WHEEZING. SHE WAS ADMITTED INTO THE MEDICAL INTENSIVE CARE UNIT (MICU) AND TREATED WITH CONTINUOUS NEBULIZED ALBUTEROL, IN ADDITION TO 80 MG OF ORAL PREDNISONE, UNDERSTANDING HER HISTORY OF PSYCHIATRIC COMPLICATIONS WITH ORAL CORTICOSTERIODS USE. HER SYMPTOMS IMPROVED SIGNIFICANTLY OVER TWO DAYS AND SHE WAS DISCHARGED HOME. THE PHYSICIAN NOTED THAT THE PATIENT'S OUTPATIENT SPIROMETRY OBTAINED IN CLINIC ONE MONTH PRIOR TO BEGINNING BT TREATMENT SHOWED AN FEV1 OF 1.06 L OR 36% OF PREDICTED. SIX MONTHS FOLLOWING COMPLETION OF HER THREE BT TREATMENTS, HER SPIROMETRY REFLECTED A SLIGHT DROP IN PULMONARY FUNCTION COMPARED TO MEASUREMENTS MADE PRIOR TO BT, WITH A FEV1 OF 0.96 L OR 32% OF PREDICTED. HOWEVER, THE PATIENT REPORTED THAT SHE WAS LESS DYSPNEIC AND HAD A SIGNIFICANT IMPROVEMENT IN HER QUALITY OF LIFE. SHE STATED THAT SHE WAS MORE ACTIVE, LESS FATIGUED, AND CAPABLE OF COMPLETING ACTIVITIES OF DAILY LIVING WITHOUT SHORTNESS OF BREATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R