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.Study source - (b)(6).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 as part of the (b)(6) clinical study.On (b)(6) 2017 the patient was admitted to the hospital as planned for the bt treatment.On (b)(6) 2017 the patient underwent the second bronchial thermoplasty procedure performed in the left lower lobe of the lungs.No issues were noted with the device.On (b)(6) 2017 the patient was discharged from the hospital following the bt treatment.According to the complainant, on (b)(6) 2017 the patient experienced lower respiratory tract infection.The patient visited the emergency room and was hospitalized to treat the infection.No additional treatment details were reported.The patient was discharged from the hospital following treatment for the infection, however, the exact discharge date was not reported.On (b)(6) 2017 the patient recovered from the lower respiratory tract infection.
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