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

Model Number 00146

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Swelling (2091); Rupture (2208); Fluid Discharge (2686)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

Vital access representatives contacted (b)(6) and spoke with (b)(6), rn on 12/6/2016.(b)(6) confirmed the site infection and reported a history of the event.The pt was non-compliant and regularly missed treatments.She also was frequently in the hospital.Consistent cannulation was difficult and recently resulted in failed v wing cannulation.The avf had developed over the past year so cannulation outside the v wing with sharp needles was possible.However, the clinic wanted to restart the v wing site.Cannulation was successful but during treatment the site infiltrated.Two days later, the site looked good, but after a weekend the site was warm to the touch.The pt was referred to the surgeon the following wed or thur and he confirmed swelling.On fri the pt observed puss at the site and she was referred to the surgeon and hospitalized.(b)(6) did not know the eventual outcome because the pt requested a transfer to the (b)(6) clinic which was effective upon pt discharge from the hospital.He thought the hematoma from the infiltration had become infected.On 12/21/2016, vital access learned that a heterograft had been implanted to replace the avf.Infected device - not provided.

Event Description

On (b)(6) 2016, dr.(b)(6) reported to vital access that he had scheduled a v wing explant for that day due to an infection at the v wing site.Dr.Rosen said there were no indications of a systemic infection.Initially, swelling at the site was thought to be a hematoma but then it ruptured and puss came from the site.Dr.(b)(6) said he was considering implanting a biologic graft to replace the avf.Previous cannulations, using blunt needles, had been considered successful.

• 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: 6252150
• MDR Text Key: 64905527
• Report Number: 3009273792-2017-00002
• 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: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 00146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• 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
• Treatment: AV FISTULA NEEDLES
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR