Model Number 4FC12 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/07/2017 |
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 cryo ablation procedure, the hemostatic valve in the sheath was defective and there was difficulty advancing the balloon.The sheath was 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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Event summary: upon visual inspection of flexcath sheath 4fc12 / (b)(4), results showed the device was intact with no apparent issues.A test catheter could be inserted inside the flexcath sheath without any issues.Air aspiration was reproduced when the arctic front catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking.In conclusion, the reported insertion issue has not been confirmed through testing.The sheath failed the returned product inspection due to a leaking hemostatic valve.
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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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