MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-03-24 for VWING VASCULAR NEEDLE GUIDE 00144 manufactured by Vital Access Corp.
[41034354]
Initially submitted to fda on 24 september 2015 as 2009273792-2015-00001, instead of 3009273792-2015-00001. Amended report with correct fei number (3009273792) submitted on 24 march 2016.
Patient Sequence No: 1, Text Type: N, H10
[41034355]
(b)(6) received two vwing implants on (b)(6) 2015. On (b)(6) 2015, both vwing sites were cannulated. It was noted that the tech was not performing double skin prep. The tech was informed to perform double skin prep to prevent any possible infection but was noted a number of times continuing to use poor practice after the initial cannulation experience. On (b)(6), a vital access representative called the clinic and was informed that (b)(6) was having issues at their venous vwing site with pus coming from the site. (b)(6) was treated with abx for over a week, from (b)(6) and all cultures were negative per the clinic. The clinic informed the vital access representative that the pus might have resulted from (b)(6) not taking care of his access site or scratching the site but this claim was not confirmed. Cannulation was resumed on (b)(6). (b)(6) was actively followed on a weekly basis. On (b)(6), a vital access representative was informed by the clinic that the venous vwing had been removed secondary to a localized site infection and that the site culture was positive for s. Aureus. No bloodstream infection present. (b)(6) arterial vwing remains implanted and in use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009273792-2015-00001 |
| MDR Report Key | 5522411 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-03-24 |
| Date of Report | 2015-09-24 |
| Date of Event | 2015-08-24 |
| Date Mfgr Received | 2015-08-26 |
| Date Added to Maude | 2016-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARK CRAWFORD |
| Manufacturer Street | 448 E. WINCHESTER ST. SUITE 250 |
| Manufacturer City | SALT LAKE CITY UT 84107 |
| Manufacturer Country | US |
| Manufacturer Postal | 84107 |
| Manufacturer Phone | 8014339390 |
| Manufacturer G1 | VITAL ACCESS CORP. |
| Manufacturer Street | 448 E. WINCHESTER ST. SUITE 250 |
| Manufacturer City | SALT LAKE CITY UT 84107 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84107 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VWING VASCULAR NEEDLE GUIDE |
| Generic Name | VWING |
| Product Code | PFH |
| Date Received | 2016-03-24 |
| Model Number | 00144 |
| Lot Number | 14-0126 |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VITAL ACCESS CORP |
| Manufacturer Address | 448 E WINCHESTER ST SUITE 250 SALT LAKE CITY UT 84107 US 84107 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-24 |