Catalog Number 934074 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pericardial Effusion (3271)
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Event Date 02/19/2024 |
Event Type
Injury
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Manufacturer Narrative
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E1: initial reporter address:(b)(6).E1: initial reporter city: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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A pediatric patient underwent open heart surgery wherein coseal surgical sealant was applied via an easyspray device with coseal spray set.Five days post operative (postop) the patient had an echocardiograph and confirmed pericardial effusion.That same day the patient started on unspecified medications for treatment of the pericardial effusion.The next day, a second echocardiograph was performed, and no improvement was noted.The patient underwent a pericardial drainage procedure, and a drainage duct was placed.The patient was hospitalized the same day.Eight days postop the patient had recovered.No further information was available at the time of this report.
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Manufacturer Narrative
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H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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