MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-24 for VWING VASCULAR NEEDLE GUIDE 00148 manufactured by Vital Access Corp..
[50295232]
The patient's venous vwing remains in place and preserved. The av fistula is expected to remain usable for dialysis access. Implanting surgeon noted that he would ask patients to contact him at the first sign of cannulation difficulty, but is "not sure what more we all could have done. " infected device - not provided.
Patient Sequence No: 1, Text Type: N, H10
[50295233]
(b)(6) was admitted with a clear cut abscess in proximity to her arterial vwing. Implanting surgeon operated - drained the pus and removed the vwing. The unit had been struggling to access the arterial spending up to an hour to gain access. The implanting surgeon believes that the cannulation staff traumatized the site and created a hematoma, which then became infected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009273792-2016-00006 |
| MDR Report Key | 5818193 |
| Date Received | 2016-07-24 |
| Date of Report | 2016-07-23 |
| Date Mfgr Received | 2016-06-24 |
| Date Added to Maude | 2016-07-24 |
| 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 | 0 |
| Brand Name | VWING VASCULAR NEEDLE GUIDE |
| Generic Name | VWING |
| Product Code | PFH |
| Date Received | 2016-07-24 |
| Model Number | 00148 |
| 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. Hospitalization; 2. Required No Informationntervention | 2016-07-24 |