Model Number 4FC12 |
Device Problem
Air Leak (1008)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/21/2015 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).
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Event Description
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It was reported that during a cryo ablation procedure, after puncturing the septum, air was bled from the side port of the sheath through the hemostatic valve.The sheath was replaced and the procedure 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 device, flexcath advance sheath 4fc12 with lot number 17458-92, was returned and analyzed.Visual inspection 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 torn.In conclusion, the reported issue of air ingress was confirmed through testing and the sheath failed the returned product inspection due to a leaking hemostatic valve.
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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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