RELIEVA SPIN SINUS GUIDE CATHETER TIP
Received Nov 12, 2014 · Event occurred Oct 13, 2014
Report 3005172759-2014-00031 · MDR key 4253401
Device
Product problems
- Detachment of Device or Device Component
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ACCLARENT WAS INFORMED OF AN EVENT THAT OCCURRED DURING A PROCEDURE IN WHICH A RELIEVA SPIN BALLOON SINUPLASTY SYSTEM WAS USED. AFTER SUCCESSFULLY DILATING THE LEFT FRONTAL SINUS, THE PHYSICIAN INSERTED THE RELIEVA SPIN F-70 SINUS GUIDE CATHETER TIP INTO THE RIGHT FRONTAL SINUS AND NOTICED THAT THE DISTAL BLUE END OF THE SINUS GUIDE CATHETER TIP WAS MISSING. THE PHYSICIAN LOCATED THE MISSING PORTION NEAR THE LEFT MAXILLARY SINUS AND RETRIEVED IT BY USING BAYONET FORCEPS. NO PATIENT INJURY WAS REPORTED.
Additional Manufacturer Narrative
THE SUBJECT DEVICE IS BEING RETURNED FOR EVALUATION. REVIEW OF MANUFACTURING RECORDS ASSOCIATED WITH THE SUBJECT DEVICE DID NOT DETECT ANY ANOMALIES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE EVALUATION FOLLOWING RECEIPT OF THE DEVICE. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES.
Remedial action
- Other