(b)(6).The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(6).(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, 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)(6) clinical study.This complaint is being reported based on the event of asthma requiring unknown medication to treat and prolonged/extended hospitalization.On (b)(6) 2017 the patient was admitted to the hospital as planned by the physician for the bronchial thermoplasty treatment.On (b)(6) 2017 the patient underwent the third bronchial thermoplasty procedure performed in the right/left upper lobe of the lungs.No issues noted with the device.According to the complainant, on (b)(6) 2017 the patient developed asthma that was treated with systemic steroids.It was necessary to extend the patient's hospitalization due to this event.On (b)(6) 2017 the patient recovered from asthma.On (b)(6) 2017 the patient was discharged from the hospital.On (b)(6) 2018 the patient developed asthma that was administered or increased with a drug to treat the asthma.The exact type of medication administered or increased to treat the asthma was not reported.It was not necessary to hospitalize the patient due to this event.On the same date, the patient recovered from asthma.
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