Model Number M001197380 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Reaction (2414)
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Event Date 06/25/2015 |
Event Type
Injury
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Manufacturer Narrative
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Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that an inflammatory reaction occurred.A mach1 guide catheter was selected to treat an aneurysm.After the embolization of an intracranial aneurysm on a case of a granulomatous meningitis, patient had an inflammatory reaction.Furthermore, regression of motor deficit was observed with the patient under corticosteroid therapy as medical intervention.
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Manufacturer Narrative
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Updated: manufacturing site name.(b)(4).
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Event Description
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It was reported that an inflammatory reaction occurred.A mach1 guide catheter was selected to treat an aneurysm.After the embolization of an intracranial aneurysm on a case of a granulomatous meningitis, patient had an inflammatory reaction.Furthermore, regression of motor deficit was observed with the patient under corticosteroid therapy as medical intervention.
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Search Alerts/Recalls
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