Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Perforation (2513); Pericardial Effusion (3271)
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Event Date 05/01/2018 |
Event Type
Injury
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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, the patient developed a pericardial effusion.The patient was then cardioverted, and ultimately, required surgery to close a hole in the anterior of the left atrium.The case was completed with cryo.The patient had an extended hospitalization, and the patient had recovered.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: data files were returned and analyzed.Data files showed that 19 injections were performed with a balloon catheter on the date of the event without triggering any system notice.The physical device was returned for analysis or investigation.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Correction: aware date of analysis.If information is provided in the future, a supplemental report will be issued.
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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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