(b)(6).The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(6).(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, 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) 2018 as part of the (b)(6) study.This complaint is being reported based on the event of peribronchiolitis typically caused by a viral infection.On (b)(6) 2018 the patient was admitted to the hospital as planned by the physician for the bronchial thermoplasty treatment.On (b)(6) 2018 the patient underwent the third bronchial thermoplasty procedure performed in the right/left upper lobe of the lungs.No issues noted with the device.According to the complainant, on (b)(6) 2018 the patient developed peribronchiolitis that was treated with systemic steroids.It was not necessary to extend the patient's hospitalization due to this event.Reportedly, the patient was presented to the emergency room (er).The number of times and dates the patient was presented to the emergency room (er) were not reported.On (b)(6) 2018 the patient was discharged from the hospital following the bronchial thermoplasty treatment.On (b)(6) 2018 the patient recovered from peribronchiolitis.
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