Catalog Number K09-10402C |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Air Embolism (1697)
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Event Date 08/19/2022 |
Event Type
Injury
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Event Description
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The account alleges that during a coronarography there was air present in the check relief valve of the manifold which results in air being injected into the patient.Patient suffered from air embolism.
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Manufacturer Narrative
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The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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Manufacturer Narrative
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The alleged device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and only one similar complaint for this lot number was identified.Should the device be returned later, the investigation will be reopened.
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Search Alerts/Recalls
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