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 11/27/2015 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).
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Event Description
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It was reported that during a cryoablation procedure, when air was being removed from the side port of the sheath, air ingress occurred from the hemostasis valve side.The sheath was replaced and the procedure 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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Investigation concluded that the data files were locked and unable to be analyzed.Therefore, this event was unable to be investigated as no product was returned.
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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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