Model Number 4FC12 |
Device Problem
Air Leak (1008)
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Patient Problems
Embolism (1829); No Known Impact Or Consequence To Patient (2692)
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Event Date 10/13/2017 |
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, upon insertion of a competitor mapping catheter in the sheath, air ingress was noted on fluoroscopy.Air aspiration was then performed using another catheter.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 seven applications were performed with catheter 2af284/92263-52 on the date of the event.Application number one was non-sustained for about 160 seconds and application number two had a temperature problem.Upon visual inspection of the flexcath sheath 4fc12 / 14977-029, results showed the device was intact with no apparent issues.Air aspiration was reproduced when a test arctic front catheter was introduced through the sheath when catheter was in the straight position.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 is torn.In conclusion, the reported issue air ingress during aspiration has been confirmed through testing but not confirmed through the data analysis.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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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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