Model Number C408646 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Death (1802)
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Event Date 11/18/2019 |
Event Type
Death
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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During the procedure, the patient expired.The vessel had instant restenosis so a balloon was used to open the vessel and oct was ran, but within five minutes the patient coded and expired.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.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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