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Model Number 4FC12 |
Device Problems
Fluid/Blood Leak (1250); Structural Problem (2506); Gas/Air Leak (2946)
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Patient Problems
Air Embolism (1697); Myocardial Infarction (1969); ST Segment Elevation (2059)
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Event Date 06/28/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product event summary: the data files and flexcath sheath, 4fc12 with lot number 04473, were returned and analyzed.The data files showed at least 12 applications were performed with a balloon catheter without any issue on the date of the event.Visual inspection of sheath showed the stopcock was intact with no apparent issues.Air aspiration was reproduced during the pressure test when the test dilator was introduced through the sheath.The hemostatic valve was leaking; the valve disk was suspected to be torn.Additionally, clinical issues (st elevation and air embolism) were encountered during the procedure.In conclusion, the air ingress 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.
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Event Description
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It was reported that during a cryoablation procedure, st segment elevation was observed after a competitor product was inserted into the manufacturer sheath.Nitorol was then administered and the st elevation recovered.The procedure continued, and it was noted that st elevation occurred again.When coronary angiography was performed, air bubble was noted in the right coronary artery (rca).Air ingress was removed until air disappeared, and the st elevation recovered.The case was completed with cryo.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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