Catalog Number UNK_NEU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vasoconstriction (2126)
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Event Date 03/19/2020 |
Event Type
Injury
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Manufacturer Narrative
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This 2 of 2 reports.The subject device is unavailable to manufacturer.
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Event Description
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It was reported that the vasospasm occurred during procedure.The medication was administered, and the outcome of the adverse event was resolved.According to the site, the relationship of the vasospasm to the subject device (distal access catheter), the balloon catheter and to the procedure.No other information was provided.
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Event Description
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It was reported that the vasospasm occurred during procedure.The medication was administered, and the outcome of the adverse event was resolved.According to the site, the relationship of the vasospasm to the subject device (distal access catheter), the balloon cathteter and to the procedure.No other information was provided.
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Manufacturer Narrative
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The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported patient vasospasm serious is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.
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Search Alerts/Recalls
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