Model Number SET ROTAREX®S 6F X 135CM |
Device Problems
Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Perforation (2001); Perforation of Vessels (2135)
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Event Date 07/13/2020 |
Event Type
Injury
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Manufacturer Narrative
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Device was discarded at the hopsital.Investigation will be performed without the device.
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Event Description
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Dr.(b)(6) cardiologist was the operator.It was an occlusion of the sfa.Vessel size was 4mm.Device was used in a 65cm 6f pinnacle sheath and over the.018 rotarex wire included with the device.The device perforated the vessel at the mid-sfa segment.The vessel was treated with a balloon, dcb and stent following the perforation.The perforation was resolved after adjunctive therapy.
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Manufacturer Narrative
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Summary evaluation report.
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Search Alerts/Recalls
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