Model Number 4FC12 |
Device Problems
Air Leak (1008); Aspiration Issue (2883)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/04/2015 |
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, after introducing the balloon catheter into the sheath, the sheath was slowly aspirated resulting in a constant draw of air.A smaller syringe was used as well as a lighter draw on the syringe, and eventually just moving the balloon in and out just slightly to seat the balloon a bit differently in the valve of the sheath.It was noted that none of this stopped the amount of air being aspirated.The sheath was then 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 device, sheath 4fc12 with lot number 47375 -19, was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issues.Air ingress was not reproduced when multiple aspirations and injections were performed.Dissection did not show any air bubbles or leaks; the hemostatic valve and valve assembly were leak tight.In conclusion, the reported issue of air aspiration was not 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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Search Alerts/Recalls
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