Model Number 4FC12 |
Device Problem
Air Leak (1008)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/25/2015 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).
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Event Description
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It was reported that during a cryo ablation procedure that after the sheath was placed, air was observed and could not be completely removed.The sheath was removed from the patient, air was expelled and the same sheath was used to complete the procedure 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 device, flexcath advance sheath 4fc12 with lot number 17453-89, was returned and analyzed.Visual inspection showed the shaft was intact with no apparent issues.Multiple aspirations and injections were performed without air bubbles or leaks and the hemostatic valve and assembly were leak tight.In conclusion, the reported issue of air ingress could not be reproduced and the sheath passed the returned product inspection.
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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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