VWING VASCULAR NEEDLE GUIDE
Received Jul 24, 2016
Report 3009273792-2016-00006 · MDR key 5818193
Device
Product problems
- Difficult to Insert
Patient
Not reported
- Abscess
- Hematoma
- Unspecified Infection
- Abscess
- Hematoma
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
THE PATIENT'S VENOUS VWING REMAINS IN PLACE AND PRESERVED. THE AV FISTULA IS EXPECTED TO REMAIN USABLE FOR DIALYSIS ACCESS. IMPLANTING SURGEON NOTED THAT HE WOULD ASK PATIENTS TO CONTACT HIM AT THE FIRST SIGN OF CANNULATION DIFFICULTY, BUT IS "NOT SURE WHAT MORE WE ALL COULD HAVE DONE." INFECTED DEVICE - NOT PROVIDED.
Description of Event or Problem
(B)(6) WAS ADMITTED WITH A CLEAR CUT ABSCESS IN PROXIMITY TO HER ARTERIAL VWING. IMPLANTING SURGEON OPERATED - DRAINED THE PUS AND REMOVED THE VWING. THE UNIT HAD BEEN STRUGGLING TO ACCESS THE ARTERIAL SPENDING UP TO AN HOUR TO GAIN ACCESS. THE IMPLANTING SURGEON BELIEVES THAT THE CANNULATION STAFF TRAUMATIZED THE SITE AND CREATED A HEMATOMA, WHICH THEN BECAME INFECTED.