DRAGONFLY DUO IMAGING CATHETER
Received Aug 1, 2019 · Event occurred Mar 20, 2019
Report 3009600098-2019-00018 · MDR key 8850683
Device
Generic name
Optical Coherence Tomography, Intravascular Catheter
Manufacturer
St. Jude Medical CatdModel number
C408644Lot number
6015539
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ONE DRAGONFLY DUO IMAGING CATHETER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THE CATHETER SHEATH HAD BEEN SEPARATED AT THE DISTAL TIP AND WAS NOT RETURNED WITH THE DEVICE. DUE TO THE RECEIVED CONDITION OF THE DEVICE, THE CATHETER DAMAGE COULD NOT BE CONCLUSIVELY ATTRIBUTED TO THE REPORTED EVENT. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE RESULTS OF THE INVESTIGATION CONCLUDED THAT THE CATHETER DISTAL TIP WAS SEPARATED FROM THE SHEATH, DISTAL TO THE LENS, AND WAS NOT RETURNED WITH THE CATHETER. THE CAUSE OF THE SEPARATED DISTAL SECTION IS CONSISTENT WITH DAMAGE DURING USE.
Additional Manufacturer Narrative
THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Description of Event or Problem
DURING THE PROCEDURE, THE CATHETER WAS UNABLE TO PASS THROUGH LESIONS. THE PROCEDURE WAS COMPLETED WITHOUT OCT WITH NO ADVERSE PATIENT CONSEQUENCES. ANALYSIS OF THE RETURNED DEVICE REVEALED THE DISTAL TIP WAS DETACHED.