Model Number 7110-0410 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage, Subarachnoid (1893); Rupture (2208)
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Event Date 05/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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The lot number was not provided.A review of the approved device history record could not be performed.The device was not returned for evaluation; therefore, a product analysis could not be performed.The root cause is unknown the instructions for use (ifu) identifies aneurysm rupture as a potential complication associated with use of the device.
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Event Description
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It was reported that balloon-assisted coil embolization was performed on a patient with a ruptured right pcomm artery aneurysm with associated subarachnoid hemorrhage.The occlusion balloon was placed at the ostium of the aneurysm.After placement of the first coil in the aneurysm, an angiogram demonstrated extravasation of contrast into the subarachnoid space.The balloon was inflated and coiling was resumed.No additional extravasation was observed afterward.There was no reported adverse patient sequela as a result.The patient was enrolled in the rage clinical trial and will be closely monitored per clinical trial protocol.
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Manufacturer Narrative
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Additional information: the lot number was provided, allowing for an exact match for the model number and a search of the production records; a search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.
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Search Alerts/Recalls
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