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Model Number 4FC12 |
Device Problems
Gas/Air Leak (2946); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/31/2019 |
Event Type
malfunction
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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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Event Description
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It was reported that during a cryo ablation procedure, upon extracting the dilator out of the sheath, the hemostatic valve was not tight, and air was able to be aspirated, indicating air ingress.The sheath was replaced and 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, 4fc12 with lot number 39641, was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issues.Deflection worked as per specification.The pressure test did not show any leak.Aspira tion/flushing test did not show any air passing through the tube or expelled from the sheath distal tip.The hemostatic valve was leak tight.In conclusion, the reported air ingress was not confirmed.The sheath passed the returned product inspection.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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