MAUDE Adverse Event Report: VITAL ACCESS CORP VWING VASCULAR NEEDLE GUIDE

Model Number 00144

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 08/24/2015

Event Type  Injury  

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.

Event Description

(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.

• Brand Name: VWING VASCULAR NEEDLE GUIDE
• Type of Device: VWING
• Manufacturer (Section D): VITAL ACCESS CORP; 448 e winchester st; suite 250; salt lake city UT 84107
• Manufacturer (Section G): VITAL ACCESS CORP.; 448 e. winchester st.; suite 250; salt lake city UT 84107
• Manufacturer Contact: mark crawford ; 448 e. winchester st.; suite 250; salt lake city, UT 84107 ; 8014339390
• MDR Report Key: 5522411
• MDR Text Key: 41034354
• Report Number: 3009273792-2015-00001
• Device Sequence Number: 1
• Product Code: PFH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 00144
• Device Lot Number: 14-0126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 3 MO
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AV FISTULA NEEDLES
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR