MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-05 for VWING VASCULAR NEEDLE GUIDE, 6MM X 7MM 00144 manufactured by Vital Access Corporation.
[4462781]
(b)(6) had two vwing devices implanted on a left upper arm brachiocephalic fistula on (b)(6) 2014. Her vwing sites were initially used to access her brachiocephalic fistula on (b)(6) 2014. Cannulations continued with a frequency of three times per week until the event. On physical examination, the sites had a 'fair amount of redness and also warmth'. After angiography, pus was 'easily able to be removed from a needle cannulation site. Therefore, the vwings were removed'. During removal of the devices, the distal vwing was observed to have 'pus within the fluted area. There was a hematoma there and also once the vwing was mobilized there was a very large defect' in the vessel wall. Due to the loss of vascular integrity, the fistula was ligated near the elbow. The sites were copiously irrigated and dried. The vwings were removed completely and the wound was packed with iodoform gauze'. The wound sites were cultured and were determined and to be a localized (b)(6) infection. No bloodstream infection or sepsis had occurred. Ns was released from the hospital the following day on (b)(6) 2014. She is currently dialyzing using a central venous catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009273792-2014-00001 |
| MDR Report Key | 3863000 |
| Report Source | 05 |
| Date Received | 2014-06-05 |
| Date of Report | 2014-05-23 |
| Date of Event | 2014-04-17 |
| Date Mfgr Received | 2014-04-23 |
| Device Manufacturer Date | 2013-10-09 |
| Date Added to Maude | 2014-06-12 |
| 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, 6MM X 7MM |
| Generic Name | VWING |
| Product Code | PFH |
| Date Received | 2014-06-05 |
| Model Number | 00144 |
| Catalog Number | 00144 |
| Lot Number | 13/0127 |
| Device Expiration Date | 2015-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2014-06-05 |