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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported from an anonymous survey result that the risk to vessel wall damage with the use of a flo-thru intraluminal shunt when used to channel (shunt) intravascular blood through a vascular anastomosis to provide a temporary blood free operative field, during peripheral vascular procedures was rated as moderate.The physician reported ¿3 total cases¿.No further detail was provided regarding if hospitalization was required, treatment for the event or the patient¿s outcome.No additional information is available.
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Manufacturer Narrative
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Additional information: h6 and h10.The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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