MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-14 for VWING VASCULAR NEEDLE GUIDE 00146 manufactured by Vital Access Corp..
[64905527]
Vital access representatives contacted (b)(6) and spoke with (b)(6), rn on 12/6/2016. (b)(6) confirmed the site infection and reported a history of the event. The pt was non-compliant and regularly missed treatments. She also was frequently in the hospital. Consistent cannulation was difficult and recently resulted in failed v wing cannulation. The avf had developed over the past year so cannulation outside the v wing with sharp needles was possible. However, the clinic wanted to restart the v wing site. Cannulation was successful but during treatment the site infiltrated. Two days later, the site looked good, but after a weekend the site was warm to the touch. The pt was referred to the surgeon the following wed or thur and he confirmed swelling. On fri the pt observed puss at the site and she was referred to the surgeon and hospitalized. (b)(6) did not know the eventual outcome because the pt requested a transfer to the (b)(6) clinic which was effective upon pt discharge from the hospital. He thought the hematoma from the infiltration had become infected. On 12/21/2016, vital access learned that a heterograft had been implanted to replace the avf. Infected device - not provided.
Patient Sequence No: 1, Text Type: N, H10
[64905528]
On (b)(6) 2016, dr. (b)(6) reported to vital access that he had scheduled a v wing explant for that day due to an infection at the v wing site. Dr. Rosen said there were no indications of a systemic infection. Initially, swelling at the site was thought to be a hematoma but then it ruptured and puss came from the site. Dr. (b)(6) said he was considering implanting a biologic graft to replace the avf. Previous cannulations, using blunt needles, had been considered successful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009273792-2017-00002 |
| MDR Report Key | 6252150 |
| Date Received | 2017-01-14 |
| Date of Report | 2017-01-13 |
| Date of Event | 2016-12-02 |
| Date Mfgr Received | 2016-11-30 |
| Date Added to Maude | 2017-01-14 |
| 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 | 2017-01-14 |
| Model Number | 00146 |
| 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 | 2017-01-14 |