The reported product is an unknown baxter vascular probe.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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It was reported from an anonymous survey result that the potential patient response risk with the use of a vascular probe/vascular probe extra supple when used in coronary surgery procedures was rated as moderate for risk of disruption of plaque, specified as ¿severe atherosclerosis¿.The risk was rated high for risk of subintimal dissection, specified as ¿insertion of the probe¿, high for risk of endothelial erosion (resulting in embolization), specified as ¿procedure while inserting the probe¿ and high for risk of vessel wall damage, specified as ¿implant and passage of the probe¿.At the time of this report, 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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