Model Number 4FC12 |
Device Problems
Air Leak (1008); Fluid/Blood Leak (1250)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 05/18/2017 |
Event Type
malfunction
|
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, while the balloon catheter was inserted into the sheath, air was aspirated and a "massive amount of air would continuously leak".A hemostatic valve leak of the sheath was suspected.The sheath was replaced with resolve.The case was completed with cryo.No patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
Event summary: the patient data files showed seven injections with catheter 2af284/73672-46 without any issues or system notices.Upon visual inspection of flexcath sheath 4fc12 / 83513-039, results showed the device was intact with no apparent issues.Air aspiration was reproduced when the arctic front catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking.In conclusion, the reported (air ingress, valve malfunction) issues have been 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.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|