Model Number 4FC12 |
Device Problem
Air Leak (1008)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059)
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Event Date 07/24/2017 |
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 cryo ablation procedure, the balloon catheter was inserted into the sheath and continuous sheath flushing was performed.The attending physician decided not to aspirate and flush the sheath when inserting the balloon catheter.While the balloon catheter was inflated in the left atrium, it was noted that air ingress occurred.A decrease in blood pressure and st elevation were confirmed.Coronary angiography was immediately performed and nitorol was injected intravenously.After some time, st elevation recovered.The case continued and 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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Product event summary: the data files were returned and analyzed.The data files showed multiple injections were performed with the catheter on the dated of the event.The sheath was not returned and inspection could not be performed.The reported air ingress, st elevation and hypotension issues were not confirmed through testing or data analysis.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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