MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-10 for VWING 00171 manufactured by Vital Access Systems.
[21875355]
Pt received implantation of 2 venous window needle guides as part of a clinical trial on (b)(6) 2012. They were successfully used for hemodialysis. The pt experienced a drop in intra-access fistula flow that was noticed on (b)(6) 2014. She underwent a fistulogram on (b)(6) 2014. The fistulogram showed a 90% stenosis of the fistula right at the downstream end of the venous window needle guide as well as other stenoses closer to the arteriovenous anastamosis. The stenoses were treated with 8mm balloon angioplasty and the flow was improved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3792910 |
| MDR Report Key | 3792910 |
| Date Received | 2014-03-10 |
| Date of Report | 2014-03-08 |
| Date of Event | 2014-03-08 |
| Date Facility Aware | 2014-03-08 |
| Report Date | 2014-03-08 |
| Date Reported to FDA | 2014-03-09 |
| Date Reported to Mfgr | 2014-03-09 |
| Date Added to Maude | 2014-05-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VWING |
| Generic Name | VASCULAR NEEDLE GUIDE |
| Product Code | PFH |
| Date Received | 2014-03-10 |
| Model Number | 00171 |
| Lot Number | 11-0093 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VITAL ACCESS SYSTEMS |
| Manufacturer Address | 2302 S. PRESIDENTS DR. SUITE # C SALT LAKE CITY UT 84120 US 84120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2014-03-10 |