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 11/21/2016 |
Event Type
malfunction
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Event Description
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It was reported that during a cryoablation procedure, air bubbles were observed when aspirating the sheath.It was noted that the balloon catheter was introduced into the sheath and was forwarded into the atrium.Every time aspiration was attempted, air bubbles were visible.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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Product event summary: the sheath was returned and visually inspected and functionally tested.Clinical data files were received and reviewed; the files showed at least 18 injections were performed with without any issue on the date of the event.Visual inspection of the sheath showed the device was intact with no apparent issues.Air aspiration was reproduced when a test catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking.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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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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