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 08/07/2017 |
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 cryoablation procedure, the sheath was flushed outside the body and when the balloon catheter was advanced into the body, there was air ingress.It was noted that an anomaly of the hemostatic valve ¿was considered¿.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 data files were returned and analyzed.The data files showed multiple applications were performed on the date of the event without any issues.The air ingress issue could not be investigated as the sheath was not returned for investigation.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 flexcath advance sheath, 4fc12 with lot 68329, 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.In conclusion, the reported issue was confirmed through testing.The sheath failed the returned product analysis due to a leaking hemostatic valve.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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