MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-24 for VWING VASCULAR NEEDLE GUIDE 00146 manufactured by Vital Access Corp..
[41023314]
Initially submitted to fda on 02 march 2016 as 2009273792-2016-00002, instead of 3009273792-2016-00002. Amended report with correct fei number (3009273792) submitted on 23 march 2016.
Patient Sequence No: 1, Text Type: N, H10
[41023315]
On (b)(6) 2016, dr. (b)(6) removed the venous upper placed vwing product code 00146 from lot# 15-0043 from patient (b)(6). This removal of vwing was as a result of a localized infection noted at the incision site. Wound was debrided and drains placed. Arterial vwing was not treated and is not in need of intervention. Following removal, the infection has resolved. The source/cause of infection is unknown. The current plan is to implant a new vwing to establish a venous access site. Vwings were initially implanted in (b)(6) on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009273792-2016-00002 |
| MDR Report Key | 5522354 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-24 |
| Date of Report | 2016-03-02 |
| Date of Event | 2016-01-20 |
| Date Mfgr Received | 2016-02-02 |
| 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 | 00146 |
| Lot Number | 15-0043 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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. Other | 2016-03-24 |