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.
|
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)(4) clinical study.On (b)(6) 2018 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) 2018 the patient experienced asthma exacerbation requiring hospitalization to be extended.The patient was treated with systemic steroids, along with the administration or increase of a drug (excluding systemic steroids), although the exact type of drug was not reported.On (b)(6) 2018 the asthma exacerbation was in remission.On (b)(6) 2018 the patient was discharged from the hospital.
|