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 on (b)(6) 2017 as part of the (b)(6) study.On (b)(6) 2017 the patient was admitted to the hospital for the bt treatment as planned by the physician.On (b)(6) 2017 the patient underwent the second bronchial thermoplasty treatment performed in the left lower lobe of the lungs.No issues were noted with the device.According to the complainant, following the procedure, the patient experienced asthma exacerbation requiring hospitalization to be extended.The patient was treated with systemic steroids for the asthma exacerbation.On (b)(6) 2017 the asthma exacerbation was in remission and the patient was discharged from the hospital.
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