DRAGONFLY¿ OPTIS¿ CATHETER
Received Jun 6, 2019 · Event occurred May 14, 2019
Report 3009600098-2019-00012 · MDR key 8675172
Device
Generic name
Dfii Kitbox Ous (no Syringe)
Manufacturer
St. Jude Medical CatdModel number
C408641Lot number
6906071
Product problems
- Flaked
- Flaked
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
Description of Event or Problem
FOLLOWING A SUCCESSFUL PROCEDURE WHEN THE DRAGONFLY OPTIS CATHETER WAS WITHDRAWN, BLACK-COLORED, FIBER-LIKE OBJECTS WERE NOTED IN THE Y-CONNECTOR. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER USE OF THE CATHETER WITH NO ADVERSE PATIENT CONSEQUENCES. THERE WAS NO DIFFICULTY INSERTING OR WITHDRAWING THE CATHETER, AND THE DEVICE DID NOT APPEAR DAMAGED. A NON-ABBOTT GUIDING CATHETER, SYRINGE, AND GUIDEWIRE WERE USED WITH THE CATHETER.
Additional Manufacturer Narrative
SEVERAL SMALL BLACK PIECES OF SUSPECTED MATERIAL WERE RETURNED, AND FTIR-ATR DETERMINED THAT THE RETURNED MATERIAL WAS NOT FROM A DRAGONFLY OPTIS DEVICE. THE DRAGONFLY OPTIS CATHETER WAS NOT RETURNED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.