Model Number 4FC12 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/29/2015 |
Event Type
malfunction
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Manufacturer Narrative
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The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).
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Event Description
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It was reported that during a cryoablation procedure, that there was blood noted oozing from the hemostasis valve of the sheath.The sheath was replaced and the case was completed with radiofrequency ablation.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 flexcath advance sheath visually inspected and functionally tested.Data files were not returned for this event.Upon visual inspection of the sheath 4fc12 / 66140-87, results showed the shaft was intact with no apparent issues and the reported air ingress could not be reproduced.Multiple aspirations and injections were performed without air bubbles or leaks.The hemostatic valve and valve assembly were leak tight.In conclusion, the reported air ingress issue has not been confirmed through testing.The sheath passed the returned product inspection as per specification.
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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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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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