Model Number 9-PFO-025 |
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 10/13/2021 |
Event Type
Injury
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Manufacturer Narrative
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Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Event Description
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It was reported on (b)(6) 2021, a 25mm amplatzer pfo occluder was selected for implant.During placement but before deployment, a pericardial effusion was noted when passing the patent foramen ovale (pfo).The occluder was successfully implanted but the effusion continued and a pericardial drainage was performed.The patient was reported to be in stable condition.The pericardial effusion was not due to the delivery system.
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Manufacturer Narrative
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An event of pericardial effusion was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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