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 12/16/2016 |
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, air ingress was noted after the sheath was inserted.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: clinical data files were received and analyzed.Five applications without issue were recorded on the date of the event.The files cannot confirm the issues of air ingress upon sheath insertion.The sheath was returned and analyzed.Visual inspection showed the shaft was intact with no apparent issues.Air aspiration was reproduced when a catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking; the valve was torn.The reported air aspiration was reproduced during 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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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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