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Model Number 4FC12 |
Device Problems
Air Leak (1008); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/08/2017 |
Event Type
malfunction
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Event Description
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It was reported that during a cryo ablation procedure, the flow was confirmed to be slightly unstable.Also, it was noted that there was something wrong with the way the temperature declined.Furthermore, the pressure was higher than usual.The coaxial umbilical cable was replaced with resolve.It was also reported that after the balloon catheter was inserted and air was removed from the side port of the sheath, air was continuously observed.A valve anomaly was suspected.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: clinical data files were received and reviewed.The reported valve issue was not confirmed through data analysis.Pending results of the analysis on returned product.
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Manufacturer Narrative
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Product event summary: the sheath, 4fc12 with lot number 67923, was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issues.Air aspiration was reproduced when a test balloon catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking; valve was torn.In conclusion, the reported issue was confirmed through analysis.The sheath, 4fc12 with lot number 67923, failed the returned product inspection due to a leaking hemostatic valve.If information is provided in the future, a supplemental report will be issued.
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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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