The product investigation was completed.Device evaluation details: visual analysis of the returned sample revealed that the hemostatic valve was found dislodged inside the hub of the vizigo sheath.A dilator was introduced with the hemostatic valve dislodged and resistance was found.Then the hemostatic valve was taken off the hub and the dilator was introduced again and no resistance was found.A microscopic examination of the hemostatic valve surface showed evidence of damage to the outer diameter.A device history record review was performed for the finished device 50000046 number, and no internal actions related to the complaint were found during the review.The issue reported by the customer was confirmed.The odp (optimal device performance guide) contains the following caution: always insert a dilator straight into the center of the sheath¿s valve to prevent damage to the valve.Do not insert a dilator at an angle, as damage to the sheath valve may occur.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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