VWING VASCULAR NEEDLE GUIDE, 6MM X 7MM
Received Jun 5, 2014 · Event occurred Apr 17, 2014
Report 3009273792-2014-00001 · MDR key 3863000
Device
Generic name
Vwing
Manufacturer
Vital Access CorporationModel number
00144Catalog number
00144
Lot number
13/0127
Product problems
- Device Operates Differently Than Expected
Patient
58 YR
- Erythema
- Hematoma
- Staphylococcus Aureus
Narrative
Description of Event or Problem
(B)(6) HAD TWO VWING DEVICES IMPLANTED ON A LEFT UPPER ARM BRACHIOCEPHALIC FISTULA ON (B)(6) 2014. HER VWING SITES WERE INITIALLY USED TO ACCESS HER BRACHIOCEPHALIC FISTULA ON (B)(6) 2014. CANNULATIONS CONTINUED WITH A FREQUENCY OF THREE TIMES PER WEEK UNTIL THE EVENT. ON PHYSICAL EXAMINATION, THE SITES HAD A 'FAIR AMOUNT OF REDNESS AND ALSO WARMTH'. AFTER ANGIOGRAPHY, PUS WAS 'EASILY ABLE TO BE REMOVED FROM A NEEDLE CANNULATION SITE. THEREFORE, THE VWINGS WERE REMOVED'. DURING REMOVAL OF THE DEVICES, THE DISTAL VWING WAS OBSERVED TO HAVE 'PUS WITHIN THE FLUTED AREA. THERE WAS A HEMATOMA THERE AND ALSO ONCE THE VWING WAS MOBILIZED THERE WAS A VERY LARGE DEFECT' IN THE VESSEL WALL. DUE TO THE LOSS OF VASCULAR INTEGRITY, THE FISTULA WAS LIGATED NEAR THE ELBOW. THE SITES WERE COPIOUSLY IRRIGATED AND DRIED. THE VWINGS WERE REMOVED COMPLETELY AND THE WOUND WAS PACKED WITH IODOFORM GAUZE'. THE WOUND SITES WERE CULTURED AND WERE DETERMINED AND TO BE A LOCALIZED (B)(6) INFECTION. NO BLOODSTREAM INFECTION OR SEPSIS HAD OCCURRED. NS WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY ON (B)(6) 2014. SHE IS CURRENTLY DIALYZING USING A CENTRAL VENOUS CATHETER.