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

Model Number	00146
Health Effect - Clinical Codes	Purulent Discharge (1812); Pneumonia (2011)
Date of Event	11/18/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Still implanted - removal scheduled.
Event or Problem Description
Patient (b)(6) had a scab over their arterial access site, which showed pus once removed.A blood culture was negative, but a skin culture at the site showed klebsiella pneumoniae.Patient received antibiotics (ancef) but refused to receive a central venous catheter during healing.Cannulations of the patient's fistula are continuing outide of the vwing sites.Vwing devices are scheduled to be removed.
Additional Manufacturer Narrative
Patient kw had a scab over their arterial access site, which showed pus once removed.A blood culture was (b)(6), but a skin culture at the site showed klebsiella pneumoniae.Patient received antibiotics (ancef) but refused to receive a central venous catheter during healing.Cannulations of the patient's fistula are continuing outside of the vwing sites.Initially, the company was informed that the vwing devices were scheduled to be removed.Upon seeing the patient, the implanting surgeon was able to further diagnose the patient.While the patient did have a cannulation-related infection, this infection was determined to be separate from the vwing devices.The patient was diagnosed with an infected hematoma.The vwing devices were both left in place in the patient while the hematoma healed.The company has been informed that the patient is now being cannulated successfully through their vwing devices again.No vwing-related serious adverse event occurred.Devices not removed - not infected.
Event or Problem Description
Patient kw had a scab over their arterial access site, which showed pus once removed.A blood culture was (b)(6), but a skin culture at the site showed klebsiella pneumoniae.Patient received antibiotics (ancef) but refused to receive a central venous catheter during healing.Cannulations of the patient's fistula are continuing outside of the vwing sites.Initially, the company was informed that the vwing devices were scheduled to be removed.Upon seeing the patient, the implanting surgeon was able to further diagnose the patient.While the patient did have a cannulation-related infection, this infection was determined to be separate from the vwing devices.The patient was diagnosed with an infected hematoma.The vwing devices were both left in place in the patient while the hematoma healed.The company has been informed that the patient is now being cannulated successfully through their vwing devices again.No vwing-related serious adverse event occurred.

• Brand Name: VWING VASCULAR NEEDLE GUIDE
• Common Device Name: VWING
• Manufacturer (Section D): VITAL ACCESS CORP.; 448 e. winchester st.; suite 250; salt lake city UT 84107
• MDR Report Key: 5522440
• Report Number: 3009273792-2015-00002
• Device Sequence Number: 16272871
• Product Code: PFH
• UDI-Device Identifier: 08199260101465
• UDI-Public: 08199260101465
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 03/31/2020
• Device Model Number: 00146
• Device Lot Number: 15-0032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/30/2015
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2016
• Supplement Report FDA Received Date: 03/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR