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.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) 2017.On (b)(6) 2017 the patient underwent the third bronchial thermoplasty treatment performed in the right and left upper lobes of the lungs.According to the complainant, during the procedure, the catheter handle icon flashed red on the alair bt controller.The physician removed the catheter from the patient to inspect the electrode array and noted that the ¿device looked intact and working well¿.There were no physical defects reported with the device.The catheter was unplugged from the controller and then plugged back in, and the catheter handle icon was no longer flashing.The procedure was completed with this device.Additionally, no bronchoscopic visualization or positioning difficulty was reported during the procedure.Following the procedure, the patient was reportedly coughing, and approximately one hour following the bt treatment, ¿full pneumothorax¿ was reported.The patient's hospitalization was prolonged due to this event.A chest tube was placed and the pneumothorax resolved on the same day.The patient was discharged from the hospital, although the exact discharge date was not reported.The patient is stable and in good condition.The resolution date for the cough was not reported.
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