INSPIRA AIR BALLOON DILATION SYSTEM
Received Jul 2, 2012 · Event occurred Jun 3, 2011
Report 3005172759-2012-00020 · MDR key 2654323
Device
Generic name
Airway Balloon Catheter
Manufacturer
Acclarent, Inc.Model number
18X40MMCatalog number
BC1840A
Lot number
UNK
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ACCLARENT RECEIVED A REPORT THAT THE SUBJECT DEVICE WAS USED IN A PROCEDURE TO EXPAND THE AIRWAY IN A PT WITH MODERATE TO SEVERE ACQUIRED TRACHEAL STENOSIS. THE PHYSICIAN INITIALLY LASERED SEVERAL INCISIONS INTO THE TRACHEAL SCAR AND MUCOUS MEMBRANE OF THE PT'S AIRWAY. THE BALLOON WAS PLACED IN THE AIRWAY AND THE SITE DILATED FOR 1-2 MINUTES. THE PHYSICIAN REPORTED THERE WAS MORE DAMAGE TO THE AIRWAY MUCOSA THAN WHAT HE EXPECTED FOLLOWING DEFLATION. AN X-RAY WAS PERFORMED, AND SHOWED NO FREE AIR IN THE CHEST OR MEDIASTINUM, AND THE PT WAS ADMITTED TO THE USER FACILITY FOR OBSERVATION OVERNIGHT. FOLLOWING THE EVENT THE PT WAS SAID TO BE DOING WELL.
Additional Manufacturer Narrative
ACCLARENT FOLLOWED UP ON THIS REPORT AND CONTACTED THE REPORTING PHYSICIAN. THE PHYSICIAN REPORTED THAT HE HAS SPECIFICALLY SELECTED A LARGE BALLOON FOR MAXIMAL DILATATION, BUT HAD NOT MEASURED THE PT'S AIRWAY PRIOR TO USING THE BALLOON. THE PT WAS SAID TO HAVE BEEN DISCHARGED THE DAY FOLLOWING THE EVENT. THE DEVICE REFERENCE IN THIS REPORT WAS NOT RETURNED FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED TEMPORARY MUCOSAL DAMAGE COULD NOT BE DETERMINED. BASED UPON THE INFORMATION PROVIDED, THE EVENT MAY HAVE BEEN RELATED TO TOO LARGE OF A BALLOON BEING USED FOR THE AIRWAY. THIS EVENT WILL BE MONITORED FOR TRENDING PURPOSES. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.