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) clinical study.(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 as part of the (b)(6) clinical study.On (b)(6) 2018, 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) 2018, the patient developed wheezing requiring hospitalization to be extended.On (b)(6) 2018, the patient recovered from the wheezing and was discharged from the hospital.
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