The patient's exact date of birth was not reported, however, it was reported that the patient's date of birth was in (b)(6).The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Study source - (b)(6).(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 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 procedure.On (b)(6) 2016 the patient underwent the first bronchial thermoplasty procedure performed in the right lower lobe of the lungs.No issues were noted with the device.The patient was discharged on (b)(6) 2016 following the bt treatment.According to the complainant, on (b)(6) 2016 the patient developed coughing.The patient visited the emergency room and was treated with systemic steroids (exact date not reported).The patient was further hospitalized, however, the exact hospitalization dates were not reported.On (b)(6) 2016 the coughing was in remission.
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