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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 10/04/2017 |
Event Type
malfunction
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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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Event Description
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It was reported that during a cryo ablation procedure, a mechanical block was observed when inserting the balloon catheter into the sheath.The catheter was replaced with resolve.Later in the procedure, the physician attempted to aspirate but was only able to aspirate air bubbles.The sheath was replaced with resolve, and 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 flexcath advance sheath, 4fc12 with lot 43600, was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issue.Air aspiration was reproduced when a test balloon catheter was introduced through the sheath.Functional testing of the sheath confirmed the hemostatic valve was leaking.Air bubbles were observed through the valve.It is suspected that the valve disk was torn.In conclusion, the reported issue of air ingress during aspiration was confirmed through testing.The sheath failed the returned product analysis due to a leaking hemostatic valve.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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