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Model Number 4FC12 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/17/2018 |
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, after isolation of the pulmonary veins, as the balloon catheter was removed from the sheath, blood continuously flowed from the hemostatic valve.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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Event summary: the patient data files showed at least ten applications were performed with catheter 2af284 / 35149-74 on the date of the event with no system notice or any issues.Upon visual inspection of the sheath 4fc12 / 79179-095, results showed the device was intact with no apparent issues.Flushing and air aspiration testing did not show any air passing through the tube or expelled from the distal tip.Functional testing of the sheath confirmed the hemostatic valve was leaking.Air bubbles were observed through the valve.We suspect the valve disk is torn.In conclusion, the reported issue air ingress during aspiration has been 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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Search Alerts/Recalls
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