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 10/11/2016 |
Event Type
malfunction
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Event Description
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It was reported that during a cryoablation procedure, shortly after entering the balloon catheter into the sheath, an air bubble was noticed in the sheath side port.A gentle aspiration of the sheath removed the bubble.The physician noted that it was possible the bubble was introduced by a defective sheath side port.The sheath was replaced and 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 clinical data files showed at least fifteen injections were performed without any issue on the date of the event.Upon visual inspection of flexcath sheath (b)(4), results show the device was intact with no apparent issues.Dissection showed that the hemostatic valve was leaking and the valve was torn.In conclusion, the reported issue has been confirmed through testing.The sheath 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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