The exact patient age was not reported, however, the patient was reported to be over the age of 18 years old.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.
|
It was reported to boston scientific corporation that an alair bronchial thermoplasty (bt) catheter was used during a bronchial thermoplasty treatment performed as part of the (b)(6) clinical study.On (b)(6) 2018 the patient was admitted to the hospital for the bt treatment as planned by the physician.On (b)(6) 2018 the patient underwent the third bt treatment 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 developed 'pneumothorax left side', requiring hospitalization to be extended.No treatment was performed for the event.On (b)(6) 2018 the patient recovered from the event and was discharged from the hospital.
|