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 11/23/2016 |
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 cryoablation procedure, it was not possible to aspirate the sheath without air.The sheath was replaced with resolve.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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Product event summary: the sheath was returned and analyzed.Visual inspection showed the device was intact with no apparent issues.Air aspiration was reproduced when a test catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking.The reported air aspiration was reproduced during testing; the sheath failed the returned product inspection due to a leaking hemostatic valve.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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Manufacturer Narrative
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Information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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