Catalog Number K12T-07955A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Air Embolism (1697); Sudden Cardiac Death (2510)
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Event Date 05/29/2018 |
Event Type
Death
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Manufacturer Narrative
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The suspect device is not expected to return for evaluation.A review of the device history and complaint database could not be performed since the lot number was not provided.
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Event Description
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The account alleges that during a selective coronary angiogram [sca], air was accidentally injected into the patient's coronary artery.The physician had acquired retrograde arterial access and had negotiated the patient's aortic root with a catheter and cannulated the coronary ostium for selective coronary artery angiograms.The physician had acquired two successful fluoroscopy runs injecting contrast into the coronary arteries without an event.The physician states that during the third selective coronary angiogram, air had somehow entered in to the system and was unintentionally injected into the patient's coronary artery resulting in the patient's death.The physician states that the injection of air within the patient was likely due to use error and not because of a product malfunction.
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Manufacturer Narrative
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The suspect device was returned for evaluation.The device was examined visually and functional testing was performed.The complaint could not be confirmed and a root cause could not be determined.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were found.
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Search Alerts/Recalls
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