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 01/10/2017 |
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, while aspirating the sheath after balloon was inserted, only air was being pulled back.This occurred with three sheaths which were all replaced in addition to the balloon catheter.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: device was returned and analyzed.Visual inspection of the sheath showed that the device was intact with no apparent issues.Air aspiration was reproduced when a test balloon catheter was introduced through the sheath.A dissection showed that the hemostatic valve was leaking.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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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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Search Alerts/Recalls
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