The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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 bt (bronchial thermoplasty) catheter was used during a bronchial thermoplasty procedure performed on (b)(6) 2018.On (b)(6) 2018 the patient was admitted to the hospital for the bronchial thermoplasty treatment.On (b)(6) 2018 the patient underwent the third bronchial thermoplasty treatment performed in the right and left upper lobes of the lungs.No issues were noted with the device.According to the complainant, following the procedure, the patient developed wheezing and was treated with systemic steroids.The patient's hospitalization was extended due to this event.On (b)(6) 2018 the patient was discharged from the hospital.On (b)(6) 2018 the patient recovered from the wheezing.
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