INSPIRA AIR BALLOON CATHETER 5X24MM

Additional Manufacturer Narrative

NO PRIOR CASE OF NEGATIVE PRESSURE PULMONARY EDEMA HAS BEEN NOTED. NO DEVICE OR LOT INFO WAS AVAILABLE. NO PRODUCT MALFUNCTION WAS NOTED. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ANY ADDITIONAL INFO AND PROVIDE SUBSEQUENT REPORTS IF REQUIRED.

Description of Event or Problem

ON (B)(6) 2010, A PHYSICIAN FROM (B)(6) CONTACTED ACCLARENT'S VP OF MEDICAL AFFAIRS REGARDING AN EVENT ASSOCIATED WITH NEGATIVE PRESSURE PULMONARY EDEMA. THE DATE OF THE PROCEDURE WAS NOTED AS (B)(6) 2010, INVOLVING A PT WITH SPONTANEOUS BREATHING. IN THE RECOVERY ROOM, THERE WAS SOME COUGHING NOTED. A CHEST X-RAY IN RECOVERY ROOM SHOWED FLUFFY PULMONARY EDEMA. AFTER A LONG STAY IN RECOVERY THIS CONDITION IMPROVED, HOWEVER, THE PT WAS NOTED TO STILL HAVE A COUGH AND REACTIVE AIRWAY THAT WAS NOT THERE BEFORE. A DIAGNOSIS OF NEGATIVE PRESSURE PULMONARY EDEMA WAS MADE. ACCORDING TO ACCLARENT'S VP OF MEDICAL AFFAIRS, WHILE THE NEGATIVE PRESSURE PULMONARY EDEMA CAN THEORETICALLY OCCUR FROM SPONTANEOUS BREATHING AGAINST THE BALLOON, IT IS AN EXTREMELY RARE PHENOMENON. ACCLARENT'S VP OF MEDICAL AFFAIRS CONSULTED ANOTHER PHYSICIAN WELL VERSED IN TREATING SUCH CASES. IN OVER 1,500 CASES OF AIRWAY STENOSIS DILATION, THE CONSULTED PHYSICIAN NOTED THAT HE HAD NEVER SEEN A CASE OF NEGATIVE PRESSURE PULMONARY EDEMA. FURTHERMORE, HE NOTED THAT IT IS IMPOSSIBLE TO KNOW HOW SHALLOW OR NOT THE SPONTANEOUS BREATHING WAS. IF THE BREATHING WAS VERY SHALLOW OR THE PT APNEIC, THEN THE CHANCE OF NEGATIVE PRESSURE PULMONARY EDEMA FROM THE BALLOON INFLATION IS ZERO. SINCE THIS WAS NOT MEASURED, IT IS DIFFICULT TO KNOW IF THE PULMONARY EDEMA OCCURRED RELATIVE TO THE BALLOON OR NOT.