The actual event date is unknown, as the event was captured from a survey.As reported, the respondent indicated a occlusion and pseudoaneurysm occurred from a unknown transradial sheath, which was related to a pms survey.The products were not returned for analysis and 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 events ¿vascular occlusion and vascular pseudoaneurysm¿ could not be confirmed.The exact cause of the reported events cannot be conclusively determined with the limited information provided.These are known complications and are listed in the ifu as such.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿possible complications include, but are not limited to: abrupt vessel closure, additional intervention, allergic reaction (device, contrast medium and medications), air embolism, infection, intimal tear, hematoma at puncture, hemorrhage, inflammation / infection / sepsis, ischemia, perforation of vessel wall, thrombus formation, peripheral nerve injury, pain, vascular complications (e.G.Intimal tear, dissection, pseudo aneurysm, perforation, rupture, spasm, occlusion).To prevent damage to the csi tip or kinking of the csi body, do not withdraw the vessel dilator while advancing and positioning the csi in the vessel.¿ 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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