Model Number 4FC12 |
Device Problems
Air Leak (1008); Fluid/Blood Leak (1250); Material Integrity Problem (2978)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/12/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that during a cryo ablation procedure, the hemostatic valve of the sheath was damaged, and backflow of blood was noted.Additionally, as air was continuously removed through the sideport of the sheath during aspiration.The sheath was then replaced with resolve.Upon removing the sheath, a crack on the valve was observed.The case was completed with cryo.No patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Product event summary: the data files and sheath, 4fc12 with lot number 07497 were returned and analyzed.The data files showed five applications were performed with a catheter on the date of the event with no issue.Visual inspection of the sheath showed the device was intact with no apparent issues.Air aspiration was reproduced when a test balloon catheter was introduced through the sheath.Functional testing of the sheath confirmed the hemostatic valve was leaking.Air bubbles were observed through the valve and the valve disk was suspected to be torn.In conclusion, the reported air ingress during aspiration was confirmed through testing.The sheath failed the returned product inspection due to a leaking hemostatic valve.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|