As reported in femoral sheaths and accessories survey the respondent indicated thrombosis with the brite tip sheath.No other information was provided.The device was not returned for analysis.A product history record (phr) review could not be performed because the lot number for this product is unknown.Without the return of the device or images for analysis, the reported customer event ¿thrombosis¿ could not be confirmed.Vessel trauma or failure to establish a heparinized saline/isotonic solution drip or routinely flush the device via the side port may have contributed to the reported event.Thrombus is a known potential complication and is listed in the ifu as such.According to the instructions for use (ifu), aspirate from the side port extension to remove any potential air.After aspiration and flushing, consider establishing a heparinized solution or suitable isotonic solution via the side port extension.The addition of a heparinized saline drip via the side port can help in the prevention of thrombus formation.Possible complications include, but are not limited to air embolism, infection, intimal tear, hematoma at the puncture site, perforation of the vessel wall, thrombus formation.Based on the information available there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
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