MAUDE Adverse Event Report: VITAL ACCESS CORPORATION VWING VASCULAR NEEDLE GUIDE, 6MM X 7MM

Model Number 00144

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Purulent Discharge (1812); Staphylococcus Aureus (2058); Skin Discoloration (2074)

Event Date 04/17/2014

Event Type  Injury  

Event Description

(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.Pn 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 proximal vwing 'did not appear infected nad had extensive sclerosis covering it'.Due to the loss of vascular integrity at the distal vwing site, 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 staph aureus infection.No bloodstream infection or sepsis had occurred.(b)(60 was released from the hospital the following day on (b)(6) 2014.She is currently dialyzing using a central venous catheter.

• Brand Name: VWING VASCULAR NEEDLE GUIDE, 6MM X 7MM
• Type of Device: VWING
• Manufacturer (Section D): VITAL ACCESS CORPORATION; salt lake city UT
• Manufacturer Contact: christopher phillips ; 2302 presidents dr; ste c; salt lake city, UT 84120-0000 ; 8014339390
• MDR Report Key: 3863001
• MDR Text Key: 4511183
• Report Number: 3009273792-2014-00002
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2015
• Device Model Number: 00144
• Device Catalogue Number: 00144
• Device Lot Number: 13-0127
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2013
• 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: 3X/WEEK (B)(6) 2014
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR