(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.
|
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 the (b)(6) clinical study.On (b)(6) 2016 the patient was admitted to the hospital as planned by the physician for the bronchial thermoplasty treatment.On (b)(6) 2016 the patient underwent the third bronchial thermoplasty procedure performed in the right/left upper lobe of the lungs.No issues noted with the device.On (b)(6) 2016 the patient was discharged from the hospital following the bronchial thermoplasty treatment.According to the complainant, on (b)(6) 2016 the patient developed asthma and was treated with systemic steroids to treat the asthma.It was not necessary to hospitalize the patient due to this event.On (b)(6) 2016 the patient recovered from the asthma.On (b)(6) 2017, the patient developed asthma and was treated with systemic steroids to treat the asthma.It was not necessary to hospitalize the patient due to this event.On (b)(6) 2017 the patient recovered from the asthma.On (b)(6) 2017, the patient developed asthma and was treated with systemic steroids to treat the asthma.It was not necessary to hospitalize the patient due to this event.On (b)(6) 2017 the patient recovered from the asthma.On (b)(6) 2017, the patient developed asthma and was treated with systemic steroids to treat the asthma.It was not necessary to hospitalize the patient due to this event.On (b)(6) 2017 the patient recovered from the asthma.On (b)(6) 2017, the patient developed homogenization pneumonia and was treated with systemic steroids to treat the pneumonia.It was not necessary to hospitalize the patient due to this event.On (b)(6) 2017 the patient recovered from the homogenization pneumonia.
|