Model Number SET ROTAREX®S 6F X 110CM |
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 06/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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Suspect device not returned yet.The return of suspect device is expected.
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Event Description
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The first case was ipsi-lateral and accessed the right cfa.We were working through a 6fr terumo short sheath.Patient had isr, wire placement was confirmed under ivus.Setup of device was performed - no problems.During use rtx the wire came back into the catheter quickly.Dr.(b)(6) performed an angiogram and noted a perforation of distal sfa.Covered stent was placed and patient was fine.
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Manufacturer Narrative
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Summary evaluation report attached.Added data to d8 and d9 and correction of initial reporter.
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Search Alerts/Recalls
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