INSPIRA AIR BALLOON DILATION SYSTEM
Received Dec 22, 2012 · Event occurred Nov 28, 2012
Report 3005172759-2012-00048 · MDR key 2887355
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
1 YR
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED A SUPERFICIAL MUCOSAL TEAR OF THE TRACHEA OCCURRED DURING AN AIRWAY DILATATION PROCEDURE IN WHICH THE SUBJECT DEVICE WAS USED. THE PT WAS BEING TREATED FOR SUBGLOTTIC AND UPPER TRACHEAL STENOSIS SECONDARY TO PROLONGED INTUBATION. THE AREA OF STENOSIS WAS DILATED USING A CATHETER WITH A 10X40 MM BALLOON, WITH THE PT'S TRACHEOSTOMY TUBE IN PLACE AND VENTILATION PROVIDED THROUGH THE TRACHEOSTOMY TUBE. THE SURGEON REPORTEDLY NOTED SOME BLEEDING AND IMMEDIATELY STOPPED THE INFLATION. A CARDIOTHORACIC SURGEON EXAMINED THE PT, AND ENDOSCOPY REVEALED A SUPERFICIAL POSTERIOR TRACHEAL WALL MUCOSAL TEAR. A CHEST X-RAY WAS NEGATIVE FOR MEDIASTINAL AIR OR PNEUMOTHORAX. FOR PRECAUTIONARY PURPOSES THE PT WAS OBSERVED OVERNIGHT AND DISCHARGED THE NEXT MORNING. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.
Additional Manufacturer Narrative
THERE WAS NO REPORT OF PRODUCT MALFUNCTION. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND ITS WHEREABOUTS ARE UNK. ACCLARENT FOLLOWED UP WITH THE USER AND WAS INFORMED THE SELECTED BALLOON WAS LIKELY TOO LARGE FOR THE PROCEDURE. THE INSPIRA AIR INSTRUCTIONS FOR USE WARNS THAT USE OF A BALLOON CATHETER THAT IS TOO LARGE FOR THE TARGETED ANATOMY MAY CAUSE DAMAGE TO THE SURROUNDING ANATOMY, AND ALSO AND INSTRUCTS USERS TO SELECT A BALLOON SIZE THAT DOES NOT EXCEED THE EXPECTED DIAMETER OF A HEALTHY AIRWAY. THIS REPORT APPEARS TO BE A CASE OF USER ERROR.