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

Device Problem Contamination (1120)

Patient Problems Bacterial Infection (1735); Erythema (1840); Fistula (1862); Occlusion (1984); Pain (1994); Staphylococcus Aureus (2058); Swelling (2091); Discharge (2225); Confusion/ Disorientation (2553)

Event Date 01/03/2016

Event Type  Injury  

Manufacturer Narrative

Initially submitted to fda on 05 february 2016 as 2009273792-2016-00001, instead of 3009273792-2016-00001.Amended report with correct fei number (3009273792) submitted on 23 march 2016.Infected device - evaluated at hospital.

Event Description

Pt presented to er with infected avf ((b)(6) 2016).Redness, swelling, heavy discharge, pain for past 2 days.She said the pain and drainage started a little while after dialysis had accessed the fistula.It got progressively worse until she presented to er.Blood cultures positive.She was taken to surgery the next day and the lower (arterial) v-wing was removed, sent to pathology.It tested (b)(6), as did the blood cultures.She is still hospitalized.Being treated with vancomycin, flagyl, meropenem, and cipro.Has since developed c.Diff and gets a little more confused every day, though ct and mri of brain are negative for ischemia.They have not been able to access the avf successfully yet.Currently dialyzing through femoral access.Avf has palpable thrill and bruit audible, but still have been unsuccessful at cannulating.

• Brand Name: VWING VASCULAR NEEDLE GUIDE
• Type of Device: VWING VASCULAR NEEDLE GUIDE
• 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: 5522103
• MDR Text Key: 41021013
• Report Number: 3009273792-2016-00001
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/05/2016

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2016
• 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: HEMODIALYSIS NEEDLES
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention