MAUDE Adverse Event Report: VITAL ACCESS CORPORATION VWING VASCULAR NEEDLE GUIDE, 10MM X 7MM

Model Number 00145

Device Problem Difficult to Insert (1316)

Patient Problems Erythema (1840); Hematoma (1884); Unspecified Infection (1930)

Event Date 04/28/2014

Event Type  Injury  

Event Description

(b)(6) was implanted with two vwing devices on a brachiobasilic fistula on her left upper arm on (b)(6) 2014.Both vwing devices were palpable following implantation.She was seen in follow up on (b)(6) and told to return in two weeks for further follow-up.She never showed for this visit.The cannulation center began using the vwing two weeks after the initial follow-up (around (b)(6)), believing that they had the go ahead.They had difficulty cannulating and attempted to cannulate multiple times.The patient was seen by dr (b)(6) on (b)(6) with tenderness and redness consistent with infection.Dr (b)(6) removed the distal (arterial) vwing.Operative findings suggested a hematoma that got infected with multiple manipulations.

• Brand Name: VWING VASCULAR NEEDLE GUIDE, 10MM 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: 3853488
• MDR Text Key: 4412757
• Report Number: 3009273792-2014-00003
• 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: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• 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: 00145
• Device Catalogue Number: 00145
• Device Lot Number: 13-0128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2014
• 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