Model Number 4FC12 |
Device Problem
Air Leak (1008)
|
Patient Problems
Air Embolism (1697); Stroke/CVA (1770); Death (1802); Embolism (1829); ST Segment Elevation (2059); Confusion/ Disorientation (2553)
|
Event Date 07/18/2017 |
Event Type
Death
|
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, air ingress occurred during aspiration and resulted in a coronary embolism.The case was aborted while the patient was under general anesthesia.The patient was sent to another hospital for special surveillance regarding potential brain embolism.The patient¿s hospitalization was extended two days.No further 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.
|
|
Event Description
|
It was further reported that the cause of death was a cerebral hemorrhage.
|
|
Manufacturer Narrative
|
Product event summary: the sheath, 4fc12 with lot number 48894 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 and it was torn.In conclusion, the reported air ingress issue was confirmed through testing.The sheath failed the returned product inspection due to a leaking hemostatic valve.Also, a clinical issue (embolism) was encountered and it was not confirmed through testing.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.
|
|
Event Description
|
(b)(6) 2018: incoming information indicated that the patient had died following the case.Further details are unknown at this time.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was further reported that the patient experienced st elevation, an air embolism and disoriented.Also, it was noted that the cerebral hemorrhage was due to the patient's condition.As the patient had an uncontrolled inr from an anticoagulation regimen.
|
|
Search Alerts/Recalls
|