Model Number 4FC12 |
Device Problem
Air Leak (1008)
|
Patient Problems
Air Embolism (1697); ST Segment Elevation (2059)
|
Event Date 11/17/2016 |
Event Type
Injury
|
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 cryoablation procedure, transient st elevation occurred.On fluoroscopy, the presence of air was identified in the left atrium and left ventricle.After the administration of nitrol, coronary angiography (cag) was performed and no significant stenosis was identified in the coronary artery.The air was aspirated using a pigtail catheter.The patient was confirmed to be conscious and without paralysis.The case was completed with cryo.No further patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
Product event summary: data files were returned and analyzed.Data files showed that on the date of the event, the catheter was used for 7 applications without issues.In conclusion: the data files showed that the console was controlling the pressure and flow properly without issues on the date of the event.Also, the sheath was not returned.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|