Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
ST Segment Elevation (2059)
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Event Date 04/05/2017 |
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, while anchoring the mapping catheter to the right inferior pulmonary vein (ripv), st elevation occurred and nitorol was administered.The patient was placed under monitoring and recovered within ten minutes.It was confirmed that there was no air embolism.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 data files were returned and analyzed.The data files showed that multiple injections were performed without any issue.The sheath was not returned for investigation.A known clinical issue was encountered during the procedure (st elevation).
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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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