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 07/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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Device was discarded at the hospital.Investigation will be performed without the device.
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Event Description
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It was reported that during a procedure in the distal popotial, the rotarex catheter perforated two small vessels while creating a fistula.Reportedly, a covered stent was placed to treat the two vessel perforations.
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Manufacturer Narrative
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Summary evaluation report attached.Added data to d8 and d9.
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Search Alerts/Recalls
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