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

Model Number 00145

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

Patient Problems Wound Dehiscence (1154); Hearing Impairment (1881); Necrosis (1971); Pocket Erosion (2013); Post Operative Wound Infection (2446)

Event Date 02/09/2016

Event Type  Injury  

Manufacturer Narrative

The physician explained that the patient had experienced problems with poorly-healing skin in the past ('crappy skin').While the vwing itself is not likely to be the cause of this patient's site dehiscence, we cannot rule out any relationship between the device and the adverse event.While two vwing devices were explanted when the patient's fistula was excised, only a single site had dehisced.Both devices were the same model: 00145.But they were from separate lots.It is possible that the vwing at the site that never healed was from either lot 15-0005 or from lot 15-0029.Lot 15-0005 was manufactured on 25 jan 2015, with an expiration date of january 2020.Lot 15-0029 was manufactured on 03 mar 2015, with an expiration date of february 2020.Initially submitted to fda on 05 march 2016 as 2009273792-2016-00003, instead of 3009273792-2016-00003.Amended report with correct fei number (b)(4) submitted on 24 march 2016.

Event Description

Patient (b)(6) was implanted on (b)(6) 2016 with two devices.He presented to the office with what appeared to be a necrosed and infected surgical incision and pocket exposing his venous vwing device.Cannulation had never been attempted both vwings were well adhered to the vessel.Dehiscence was observed at the venous vwing site following implantation.All cultures were negative.Patient (b)(6) had a history of poor-healing skin.The reason for placing vwings had been to avoid a long superficialization incision because of the pre-existing skin healing condition.Implanting surgeon stated that patient "just had crappy skin." fistula was abandoned and both vwing devices were explanted on (b)(6) 2016, and replaced with a vein graft.The open vwing site was left open and packed with saline dressing.

• 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: 5522385
• MDR Text Key: 41027233
• Report Number: 3009273792-2016-00003
• 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: 03/05/2016

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: 00145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2015
• 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; Required Intervention; Disability
• Patient Age: 51 YR
• Patient Weight: 105