Model Number H7493927615350 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Intimal Dissection (1333)
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Event Type
Injury
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Manufacturer Narrative
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Device evaluated by mfr: the complaint device was not received for analysis.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
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Event Description
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Same case as mdr#2134265-2017-11231.It was reported during a conference that vessel dissection occurred.Vascular access was obtained via the retrograde approach.Following dilatation with a 2.25x15 emerge balloon and a 3.50x15mm nc emerge balloon, intravascular ultrasound was performed which revealed that the guidewire had been inserted in the subintima and vascular dissection had occurred.The physician inserted the guidewire into the true lumen and three stents were implanted to complete the procedure.No patient complications were reported.
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Search Alerts/Recalls
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