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)(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) 2017 as part of the (b)(4) clinical study.On (b)(6) 2017 the patient was admitted to the hospital for the bronchial thermoplasty procedure as planned by the physician.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, on (b)(6) 2017 the patient developed bronchial infection and was treated with the administration or increase of a drug (excluding systemic steroids), although the exact type of medication was not reported.On (b)(6) 2017 the bronchial infection was in remission.The physician assessed that it was unknown if the event was related to the patient¿s third bronchial thermoplasty procedure.
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