Model Number 4FC12 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/07/2020 |
Event Type
malfunction
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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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Event Description
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It was reported that during a cryo ablation procedure, air was injected into the syringe by aspiration through the sheath.The balloon catheter was replaced.The case was completed with cryo.
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Manufacturer Narrative
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Correction: b5.If information is provided in the future, a supplemental report will be issued.
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Event Description
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No patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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