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 11/07/2018 |
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, vital signs were not stable and an epicardial effusion was observed by an echocardiogram.A pericardial puncture was performed to drain the effusion.It was further reported that bleeding could not be stopped, and the patient was transferred to the cardiac department of another facility.The case was aborted and it was noted that the patient was not under general anesthesia.The physician noted that a perforation occurred before the balloon catheter was inserted.No further patient complications have been reported as a result of this event.
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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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Manufacturer Narrative
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Product event summary: the data files were returned and analyzed.The data files showed at least 7 applications were performed with balloon catheter 2af284 with lot number 85292, without any issue on the date of the event.Clinical issues were encountered during the procedure.There is no indication of a relation of the adverse events to the performance of the physical product.The balloon catheter was not returned for investigation.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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