Model Number 4FC12 |
Device Problem
Air Leak (1008)
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Patient Problem
Air Embolism (1697)
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Event Date 01/19/2017 |
Event Type
Injury
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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 cryoablation procedure, electrocardiogram showed st elevation after the balloon temperature was rewarmed and the balloon was deflated.Nitroglycerin was given to the patient with resolve.However, fluoroscopy showed air remained in the left atrial appendage.The physician mistakenly still opened one of triple-three-way stopcock connecting to the balloon catheter while balloon occlusion in the left superior pulmonary vein was checked.It was confirmed that was why air ingress occurred.The balloon catheter was removed from the sheath and air was removed again.Air in the left atrial appendage was removed using the sheath.The case was completed with cryo.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Event summary: the patient data files cannot show the reported issue (air ingress in the system, embolism, st elevation) on the event date.At least nine applications were performed with catheter (b)(4) on the date of the event with no detected issue.No products were returned.In conclusion, this is a clinical issue (st elevation) during the case.Products (b)(4) were not returned.
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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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