RELIEVA FLEX SINUS GUIDE CATHETER
Received Dec 18, 2013 · Event occurred Nov 25, 2013
Report 3005172759-2013-00040 · MDR key 3724594
Device
Product problems
- Detachment Of Device Component
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE PHYSICIAN STATED THAT THERE WAS NO PATIENT INJURY AND THE TIP WAS REMOVED EASILY BY FORCEPS. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVALUATION, AND ITS WHEREABOUTS ARE UNKNOWN. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.
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 OF THE GUIDE CATHETER CAME OFF IN THE MIDDLE MEATUS. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP ENDOSCOPICALLY.
Remedial action
- Other