Model Number 4FC12 |
Device Problem
Air Leak (1008)
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Patient Problems
ST Segment Elevation (2059); No Known Impact Or Consequence To Patient (2692)
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Event Date 07/27/2016 |
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 cryoablation procedure, "when the patient took a breath, there was a high possibility that air could enter from the valve of the sheath".The sheath was replaced with a competitor product.The procedure completed with cryo.No further 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 data files and sheath, 4fc12 with lot number 75945 were returned and analyzed.The data files did not show any system notices or issues for the date of the reported event.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 air ingress and valve issue were confirmed through testing.The sheath failed the returned product inspection due to a leaking hemostatic valve.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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Search Alerts/Recalls
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