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)(4).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.
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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 as part of (b)(6) study.On (b)(6) 2016 the patient was admitted to the hospital for the bronchial thermoplasty procedure.On (b)(6) 2016 the patient underwent the second bronchial thermoplasty procedure performed in the left lower lobe of the lungs.No issues were noted with the device.According to the complainant, on (b)(6) 2016 the patient developed asthma exacerbation and was treated with systemic steroids.On (b)(6) 2016 the asthma exacerbation was in remission.On (b)(6) 2016 the patient developed asthma exacerbation and was treated with systemic steroids.The patient was hospitalized due to the event, although the exact hospitalization dates were not reported.On (b)(6) 2016 the asthma exacerbation was in remission.
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