Acclarent was informed of an event on (b)(6) 2016, which occurred on (b)(6) 2015, during a balloon sinuplasty in-office (bspio) procedure in which the patient experienced an adverse reaction.During the procedure the patient was administered 30 mg of liquid versed (midazolam).Later in the procedure the patient was reported to have struggled to remain conscious.The physician was able to successfully dilated both frontal sinuses and right maxillary sinus.The patient was bleeding heavily from the nose and appeared to have soiled himself and aspirated on his vomit.The physician attempted to clear the patient's airway with a yankauer suction and attempted to administer oxygen to the patient.Emergency medical service (ems) was dispatched by 911 service.The patient was reported to have low oxygen saturation (~80%) but was stable and semi-conscious.The patient was transported via ambulance to the hospital.There was no reported malfunction with any of the acclarent products used during the case.Thus, this event is unrelated to the devices and most likely related to the procedure or patient's pre-existing condition.The patient's current condition is not known.
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