MAUDE Adverse Event Report: VITAL ACCESS CORPORATION VENOUS WINDOW NEEDLE GUIDE (V-WING)

Model Number 7 MM, DEPTH 8MM

Device Problems Filling Problem (1233); Device Operates Differently Than Expected (2913); No Flow (2991)

Patient Problem Pain (1994)

Event Date 12/10/2013

Event Type  Injury  

Event Description

Pt complained of difficulty with cannulation with venous window needle guide also known as v-wing device.She has not been using v-wing for cannulation of the fistula for purpose of hemodialysis since (b)(4) 2013.Additionally, there was a complaint of pain on cannulation through the device and difficulty to obtain adequate blood return through v-wing site.Distal v-wing site problems were worse than the proximal.

• Brand Name: VENOUS WINDOW NEEDLE GUIDE (V-WING)
• Type of Device: V-WING
• Manufacturer (Section D): VITAL ACCESS CORPORATION; 2302 president dr.; stu c; west valley city UT 84120
• MDR Report Key: 3653225
• MDR Text Key: 4201359
• Report Number: 3653225
• Device Sequence Number: 1
• Product Code: PFH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2013
• Device Model Number: 7 MM, DEPTH 8MM
• Device Catalogue Number: 0071
• Device Lot Number: 11-0093
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/13/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2014
• Distributor Facility Aware Date: 01/09/2014
• Device Age: 15 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/13/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SURGICAL REMOVAL OF TWO IMPLANTED V-WING DEVICES
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 98