Model Number 4FC12 |
Device Problems
Air Leak (1008); Fluid Leak (1250)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 05/05/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
A good faith effort will be made to obtain the applicable information relevant to the report.
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 sheath had a leaky valve and was pulling air.
The sheath was replaced and the case was completed with cryo.
No patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
Product event summary: the flexcath advance sheath, 4fc12 with lot 70095, was returned and analyzed.
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.
Dissection showed the hemostatic valve was leaking; the valve was torn.
In conclusion, the reported issue was confirmed through testing.
The sheath failed the returned product inspection due to a leaking hemostatic valve.
|
|
Search Alerts/Recalls
|