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).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) 2016 as part of (b)(6) study.This complaint is being reported based on the event of bronchitis treated with medication (exact type not reported).On (b)(6) 2016 the patient was admitted to the hospital for the bronchial thermoplasty procedure as planned by the physician.On (b)(6) 2016 the patient underwent the first bronchial thermoplasty procedure performed in the right lower lobe of the lungs.No issues were noted with the device.According to the complainant, on (b)(6) 2016 the patient developed bronchitis 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) 2016 the patient had recovered from the bronchitis.
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