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Model Number 9-ITV10F45/80 |
Device Problem
Device Handling Problem (3265)
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Patient Problems
Air Embolism (1697); Infarction, Cerebral (1771); Loss of consciousness (2418)
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Event Date 05/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.
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Event Description
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On (b)(6) 2020, just prior to deploying the device, the physicians noticed that air had got into the left ventricle (air embolism) and the patient wasn¿t responding.Air was aspirated however patient still had suffered a stroke which imaging had confirmed post procedure.The physician deployed the device to prevent further complications.The user, along with other physicians present during the procedure, agreed it was likely caused by taking out the ¿introducer¿ too quickly thus allowing air to enter.Patient is recovering well.
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Manufacturer Narrative
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Additional information: g4,h2, h3, h6, h10.An event of an air embolism was reported.A more comprehensive assessment could not be performed since 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 at the time of commercialization.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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