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 11/03/2016 |
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 cryo ablation procedure, there was leakage from the hemostatic valve of the sheath.The sheath was replaced.The procedure was continued and 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: data files and the device, sheath flexcath sheath 4fc12 with lot number 92123-085, were returned and analyzed.The data files showed an unrelated system notice.Visual inspection of the device showed it 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 and torn.In conclusion, the reported issued of air ingress was confirmed through testing and the returned product failed the returned product inspection due to a leaking hemostatic valve.
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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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