MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-28 for VWING VASCULAR NEEDLE GUIDE, 10MM X 7MM 00145 manufactured by Vital Access Corporation.
[4412757]
(b)(6) was implanted with two vwing devices on a brachiobasilic fistula on her left upper arm on (b)(6) 2014. Both vwing devices were palpable following implantation. She was seen in follow up on (b)(6) and told to return in two weeks for further follow-up. She never showed for this visit. The cannulation center began using the vwing two weeks after the initial follow-up (around (b)(6)), believing that they had the go ahead. They had difficulty cannulating and attempted to cannulate multiple times. The patient was seen by dr (b)(6) on (b)(6) with tenderness and redness consistent with infection. Dr (b)(6) removed the distal (arterial) vwing. Operative findings suggested a hematoma that got infected with multiple manipulations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009273792-2014-00003 |
| MDR Report Key | 3853488 |
| Report Source | 05 |
| Date Received | 2014-05-28 |
| Date of Report | 2014-05-28 |
| Date of Event | 2014-04-28 |
| Date Mfgr Received | 2014-04-28 |
| Device Manufacturer Date | 2013-10-09 |
| Date Added to Maude | 2014-06-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRISTOPHER PHILLIPS |
| Manufacturer Street | 2302 PRESIDENTS DR STE C |
| Manufacturer City | SALT LAKE CITY UT 841200000 |
| Manufacturer Country | US |
| Manufacturer Postal | 841200000 |
| Manufacturer Phone | 8014339390 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VWING VASCULAR NEEDLE GUIDE, 10MM X 7MM |
| Generic Name | VWING |
| Product Code | PFH |
| Date Received | 2014-05-28 |
| Model Number | 00145 |
| Catalog Number | 00145 |
| Lot Number | 13-0128 |
| Device Expiration Date | 2015-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VITAL ACCESS CORPORATION |
| Manufacturer Address | SALT LAKE CITY UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-05-28 |