VWING VASCULAR NEEDLE GUIDE

Additional Manufacturer Narrative

INITIALLY SUBMITTED TO FDA ON 24 SEPTEMBER 2015 AS 2009273792-2015-00001, INSTEAD OF 3009273792-2015-00001. AMENDED REPORT WITH CORRECT FEI NUMBER (3009273792) SUBMITTED ON 24 MARCH 2016.

Description of Event or Problem

(B)(6) RECEIVED TWO VWING IMPLANTS ON (B)(6) 2015. ON (B)(6) 2015, BOTH VWING SITES WERE CANNULATED. IT WAS NOTED THAT THE TECH WAS NOT PERFORMING DOUBLE SKIN PREP. THE TECH WAS INFORMED TO PERFORM DOUBLE SKIN PREP TO PREVENT ANY POSSIBLE INFECTION BUT WAS NOTED A NUMBER OF TIMES CONTINUING TO USE POOR PRACTICE AFTER THE INITIAL CANNULATION EXPERIENCE. ON (B)(6), A VITAL ACCESS REPRESENTATIVE CALLED THE CLINIC AND WAS INFORMED THAT (B)(6) WAS HAVING ISSUES AT THEIR VENOUS VWING SITE WITH PUS COMING FROM THE SITE. (B)(6) WAS TREATED WITH ABX FOR OVER A WEEK, FROM (B)(6) AND ALL CULTURES WERE NEGATIVE PER THE CLINIC. THE CLINIC INFORMED THE VITAL ACCESS REPRESENTATIVE THAT THE PUS MIGHT HAVE RESULTED FROM (B)(6) NOT TAKING CARE OF HIS ACCESS SITE OR SCRATCHING THE SITE BUT THIS CLAIM WAS NOT CONFIRMED. CANNULATION WAS RESUMED ON (B)(6). (B)(6) WAS ACTIVELY FOLLOWED ON A WEEKLY BASIS. ON (B)(6), A VITAL ACCESS REPRESENTATIVE WAS INFORMED BY THE CLINIC THAT THE VENOUS VWING HAD BEEN REMOVED SECONDARY TO A LOCALIZED SITE INFECTION AND THAT THE SITE CULTURE WAS POSITIVE FOR S. AUREUS. NO BLOODSTREAM INFECTION PRESENT. (B)(6) ARTERIAL VWING REMAINS IMPLANTED AND IN USE.