RELIEVE FLEX SINUS GUIDE CATHETER
Received Jan 3, 2014 · Event occurred Dec 17, 2013
Report 3005172759-2014-00001 · MDR key 3757368
Device
Product problems
- Detachment Of Device Component
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ACCLARENT WAS NOTIFIED ON (B)(6) 2013 OF AN EVENT DURING A SINUS SURGICAL CASE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WAS USED. THE PHYSICIAN TRIED TO ACCESS THE RIGHT MAXILLARY SINUS AND THE BLUE TIP CAME OFF. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DETACHED TIP. THERE WAS NO PT INJURY.
Additional Manufacturer Narrative
COMPLAINT DEVICES ARRIVED ON (B)(6) 2013 AND FAILURE ANALYSIS WAS PERFORMED ON (B)(6) 2013. THE RETURNED PACKAGE INCLUDED A FLEX GUIDE CATHETER. THE BLUE TIP WAS DETACHED FROM THE GUIDE CATHETER. THE DETACHED TIP RETURNED WITH THE PACKAGE. IT IS SUSPECTED THAT THE DAMAGE COULD BE THE RESULT OF EXCESSIVELY AGGRESSIVE USE BY THE SURGEON. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.
Remedial action
- Other