RELIEVA INSPIRA AIR BALLOON CATHETER

Description of Event or Problem

ON (B)(6) 2011, ACCLARENT RECEIVED AWARENESS OF AN EVENT INVOLVING PT DEATH NOTED TO HAVE OCCURRED IN (B)(6) OF 2011. THE PT WAS AN (B)(6) CHILD WITH THIN WEBBED SUBGLOTTIC STENOSIS (NARROWING OF THE SUBGLOTTIC AIRWAY) REQUIRING A TRACHEOTOMY AT BIRTH. THE CHILD HAD SUFFERED (B)(6) AND (B)(6) AROUND THE TIME OF BIRTH CAUSING GLOBAL DELAY IN DEVELOPMENT AND ADDITIONAL NEUROLOGIC PROBLEMS. IT WAS DECIDED TO EVALUATE THE CHILD FOR AIRWAY MANAGEMENT TO SEE IF THE TRACHEOTOMY TUBE COULD BE REMOVED MAKING CARE EASIER AT THE (B)(6). AT THE TIME OF THE EVAL UNDER ANESTHESIA, A THIN SUBGLOTTIC STENOSIS WAS SEEN JUST ABOVE THE TRACHEOTOMY TUBE. THE PHYSICIAN USED A 7 MM INSPIRA AIR ACCLARENT BALLOON AND DILATED THREE TIMES FOR ABOUT 30 SECONDS EACH. THERE WAS NO BLEEDING. THE MUCOSA (MOIST TISSUE THAT LINES THE TREATED AREA) WAS NOTED TO BE "PERFECT." THE CHILD WAS KEPT IN THE RECOVERY ROOM FOR SEVERAL HOURS AND THEN WAS DISCHARGED THE SAME DAY TO THE REHABILITATION FACILITY. THE PHYSICIAN LEARNED FROM THE DIRECTOR OF THE REHABILITATION FACILITY THAT AT MIDNIGHT OF POST OPERATIVE DAY 1, THE CHILD RECEIVED A RESPIRATORY THERAPY NEBULIZED TREATMENT (MEDICATION IN THE FORM OF A MIST). THERE WAS NO OR MINIMAL AIRWAY DISTRESS OUT OF THE ORDINARY. ABOUT ONE HOUR LATER THE CHILD WAS FOUND DEAD. THE TRACHEOTOMY TUBE WAS IN PLACE AND NOT OCCLUDED. AN AUTOPSY WAS PERFORMED AND THE AIRWAY WAS NOTED TO BE PERFECT WITH NO EDEMA (OBSERVABLE SWELLING). THERE WERE NO OTHER FINDINGS. THE PHYSICIAN BELIEVES THAT THIS CHILD DID NOT DIE FROM AN AIRWAY EVENT BUT RATHER SOME TYPE OF NEUROLOGIC OR METABOLIC PHENOMENON. HE STATED THAT THE ACCLARENT INSPIRA AIR TECHNOLOGY PERFORMED AS EXPECTED. HE FELT THE RESULTS WERE EXCELLENT. ALTHOUGH THE UNFORTUNATE DEATH OF THE PT IS NOT BELOVED TO BE DEVICE RELATED, ACCLARENT HAS DEEMED THIS EVENT TO BE REPORTABLE TO THE FDA DUE TO THE SERIOUSNESS OF THE EVENT, AS WELL AS FOR INFORMATIVE PURPOSES. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ANY ADDITIONAL INFO AND PROVIDE SUBSEQUENT REPORTS IF REQUIRED.

Additional Manufacturer Narrative

NO DEVICE MALFUNCTION WAS NOTED. ACCLARENT'S AIRWAY DILATING TOOLS WERE NOTED TO HAVE PERFORMED WITHOUT FAULT AND AS EXPECTED. THE DEVICE WAS NOT AVAILABLE FOR EVAL. NO LOT INFO WAS PROVIDED. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ANY ADDITIONAL INFO AND PROVIDE SUBSEQUENT REPORTS IF REQUIRED.