RELIEVA SINUS BALLOON INFLATION DEVICE

Description of Event or Problem

EVENT DESC: WHEN ATTEMPTING TO USE THE SINUS BALLOON INFLATION DEVICE, THE DEVICE WOULD NOT INFLATE THE BALLOON. A SECOND DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. HEALTH PROFESSIONAL'S IMPRESSION. UNKNOWN. MFR RESPONSE FOR SINUS BALLOON INFLATION. DEVICE, RELIEVA. MFR PROVIDED RGA# FOR PRODUCT RETURN EVAL.

Additional Manufacturer Narrative

ON (B)(6) 2010, ACCLARENT RECEIVED A COPY OF THE MEDWATCH FORM FILED BY (B)(6) HOSPITAL CENTER. THE MEDWATCH FORM WAS ASSOCIATED WITH EXISTING COMPLAINT: (B)(4). THE REPORTED COMPLAINT WAS "FAILURE TO INFLATE". AN INFLATION DEVICE ASSOCIATED WITH THIS COMPLAINT WAS RECEIVED ON (B)(6) 2010 AND WAS TESTED WITH A SAMPLE BALLOON CATHETER. NO ABNORMAL OBSERVATIONS WERE NOTED. NOTE, INFLATION DEVICES AND BALLOON CATHETERS WORK TOGETHER AS A SYSTEM. A LOT HISTORY RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL SPECIFICATIONS. NO TRENDS HAVE BEEN IDENTIFIED WITH INFLATION DEVICE FAILURES OR THE INABILITY TO INFLATE BALLOON CATHETERS. AS DEFINED IN MEDICAL DEVICE REPORTING REGULATION TITLE 21, PART 803, NO PT INJURY, INTERVENTION TO PREVENT A SERIOUS INJURY, OR MALFUNCTION THAT COULD LEAD TO A SERIOUS INJURY WAS REPORTED IN THIS CASE. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ANY ADDITIONAL INFO AND PROVIDE SUBSEQUENT REPORTS IF REQUIRED.