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 12/10/2015 |
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 cryo ablation procedure fluid leaked out of the valve of the sheath.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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Product event summary: the flexcath advance sheath 4fc12 with lot number 75953-97 was returned and analyzed.Visual inspection showed the device was intact with no apparent issues.Air aspiration was reproduced with introduction of a test balloon catheter.Dissection of the device showed the hemostatic valve was leaking.In conclusion, the reported issue of a leaking hemostatic valve has been confirmed through testing.
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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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