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 07/24/2017 |
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, an attempt was made to aspirate air using a syringe from the sheath side port but air was continuously introduced.The position of the side port and sheath were confirmed and the syringe was pulled out slowly but air was continuously introduced.The sheath was replaced with resolve.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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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product event summary: the sheath, 4fc12 with lot number 58307 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.In conclusion, the reported issue was confirmed through testing.The sheath failed the return 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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Search Alerts/Recalls
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