Model Number 4FC12 |
Device Problem
Air Leak (1008)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/16/2017 |
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, the sheath was inserted into the left atrium when aspiration was performed and air was observed.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
|
Product event summary: clinical data files were received and analyzed.The bin files showed twelve injections with the balloon catheter but could not confirm the reported issue with the sheath.The sheath 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 reported issue has been confirmed through testing.The sheath failed the returned product inspection due to a leaking hemostatic valve.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.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|