Model Number 4FC12 |
Device Problem
Air Leak (1008)
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Patient Problem
ST Segment Elevation (2059)
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Event Date 05/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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It was reported that during a cryo ablation procedure, bubbles were observed when the sheath was aspirated.The case was completed with cryo.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the sheath, 4fc12 was returned and analyzed.Visual inspection of the sheath showed the stopcock 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 valve was torn.A clinical issue was also encountered during the case.In conclusion, the reported 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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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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