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 10/27/2016 |
Event Type
malfunction
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Event Description
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It was reported that during a cryo ablation procedure, while the sideport of the sheath was flushed, air was removed slowly but was not able to be fully removed.The sheath was replaced with resolve and the procedure continued without issue.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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Data files were returned and analyzed.Data files confirmed that the system notice was received indicating that the refrigerant delivery path was obstructed ((b)(4)) was confirmed at the 5th application with the balloon catheter.In conclusion, the reported system notice indicating that the refrigerant delivery path was obstructed ((b)(4)) was confirmed through data analysis.Pending results of the analysis on the returned product.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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Product event summary: the device was returned and analyzed.Visual inspection of the flexcath sheath showed that the stopcock was intact with no apparent issues.Air aspiration was reproduced when a test catheter was introduced through the sheath.A dissection showed that the hemostatic valve was leaking and torn.In conclusion, the reported air ingress issue was 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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