Model Number 4FC12 |
Device Problems
Air Leak (1008); Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/14/2017 |
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, air ingress was observed.The sheath was replaced without resolve; the same issue was observed with the replacement sheath.The sheath was replaced again 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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Event summary: the patient data files showed at least eight applications were performed with catheter 2af283/09560-85 on the date of the event; system notice (#50012) indicating that the refrigerant delivery path was obstructed was triggered in first application.There were flow and temperature oscillation in application number six.Upon visual inspection of flexcath sheath 4fc12 / 75706-029, results showed the device was intact with no apparent issues.Air aspiration was reproduced when a test arctic front catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking and the valve was torn.The sheath failed the test due to leaking homeostatic valve.In conclusion, the reported issue (air ingress) has been confirmed through testing.Aspiration issue not reproduced on both flex cath.The sheath 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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