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.(b)(4).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 underwent the third bronchial thermoplasty procedure 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 on (b)(6) 2017, the patient developed asthma exacerbation, cough, atelectasis, dyspnea, and wheezing.These events required hospitalization to be extended and patient was treated with systemic steroids.On (b)(6) 2017 the patient¿s condition had improved and the patient was discharged from the hospital.
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