Model Number 4FC12 |
Device Problems
Air Leak (1008); Fluid/Blood Leak (1250)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/28/2018 |
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, bubbles were observed when the sheath was aspirated.The balloon catheter was removed and the physician tried a couple of times to aspirate with no resolve.It was noted that it "looked like some valve inside didn't work properly".The sheath was replaced with resolve.The case was aborted.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 sheath, 4fc12 with lot number 70123 was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issues.Functional testing of the sheath confirmed the hemostatic valve was leaking.Air bubbles were observed through the valve.The valve disk was suspected to be torn.In conclusion, the reported issue 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
|