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)(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) 2016.This complaint is being reported based on the event of asthma exacerbation requiring medication to treat (exact type not reported).On (b)(6) 2016 the patient was admitted to the hospital as planned by the physician for the bt procedure.On (b)(6) 2016 the patient underwent the third bt 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) 2016 the patient developed peribronchial inflammation which required no treatment.On (b)(6) 2016 the peribronchial inflammation was resolved.On (b)(6) 2016 the patient experienced asthma exacerbation and was given systemic steroids for treatment, along with the administration or increase of a drug (excluding systemic steroids), although the exact type of drug was not reported.On (b)(6) 2016 the asthma exacerbation resolved.
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