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

Model Number 00146

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 01/20/2016

Event Type  Injury  

Manufacturer Narrative

Initially submitted to fda on 02 march 2016 as 2009273792-2016-00002, instead of 3009273792-2016-00002.Amended report with correct fei number (3009273792) submitted on 23 march 2016.

Event Description

On (b)(6) 2016, dr.(b)(6) removed the venous upper placed vwing product code 00146 from lot# 15-0043 from patient (b)(6).This removal of vwing was as a result of a localized infection noted at the incision site.Wound was debrided and drains placed.Arterial vwing was not treated and is not in need of intervention.Following removal, the infection has resolved.The source/cause of infection is unknown.The current plan is to implant a new vwing to establish a venous access site.Vwings were initially implanted in (b)(6) on (b)(6) 2016.

• 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: 5522354
• MDR Text Key: 41023314
• Report Number: 3009273792-2016-00002
• Device Sequence Number: 1
• Product Code: PFH
• UDI-Device Identifier: 08199260101465
• UDI-Public: 08199260101465
• 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: 03/02/2016

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: Physician
• Device Model Number: 00146
• Device Lot Number: 15-0043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2016
• 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
• Patient Outcome(s): Other