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

Model Number 00148

Device Problem Difficult to Insert (1316)

Patient Problems Abscess (1690); Hematoma (1884); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The patient's venous vwing remains in place and preserved.The av fistula is expected to remain usable for dialysis access.Implanting surgeon noted that he would ask patients to contact him at the first sign of cannulation difficulty, but is "not sure what more we all could have done." infected device - not provided.

Event Description

(b)(6) was admitted with a clear cut abscess in proximity to her arterial vwing.Implanting surgeon operated - drained the pus and removed the vwing.The unit had been struggling to access the arterial spending up to an hour to gain access.The implanting surgeon believes that the cannulation staff traumatized the site and created a hematoma, which then became infected.

• 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: 5818193
• MDR Text Key: 50295232
• Report Number: 3009273792-2016-00006
• 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: 07/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 00148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention