Catalog Number UNK DRAGONFLY |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Air Embolism (1697); Cardiac Arrest (1762)
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Event Date 09/16/2019 |
Event Type
Death
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Manufacturer Narrative
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The udi number is ¿ni¿ as the catalog number was not provided.The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that during the procedure the dragonfly imaging catheter was inserted into the patient however a large quantity of air was accidentally injected into the patient¿s heart and the patient went into cardiac arrest.Cpr was performed however the patient died.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for analysis.The device history record (dhr) for this product could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.Based on the case information, there was no conclusive cause(s) for the reported patient effects, and their respective relationship to the product, if any, that could be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.
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Event Description
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Subsequent to the initially filed medwatch report additional information was received.An autopsy was performed and per the physician, the patients death was not caused by any fault in the oct equipment used.The oct equipment obtains images from within the coronary artery and separate equipment is for contrast injection.It is possible there could have been an issue with the connector tubing between the automated contrast injector and the manifold.However, the most likely cause is human error either when checking for air or when making the connections.I acknowledge there is no evidence to suggest that there was a failure of the single use components and confirm that capital and coast district health board (ccdhb) does not maintain that the air embolism was caused by an equipment failure.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for analysis.The device history record (dhr) for this product could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.Based on the case information, there was no conclusive cause(s) for the reported patient effects, and their respective relationship to the product, if any, that could be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.H6: health effect - clinical code 1697, 1762 removed h6: health effect - impact code 1802, 4641 removed h6: investigation conclusions code 4315 removed.
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Search Alerts/Recalls
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