MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-24 for VWING VASCULAR NEEDLE GUIDE manufactured by Vital Access Corp..
[41021013]
Initially submitted to fda on 05 february 2016 as 2009273792-2016-00001, instead of 3009273792-2016-00001. Amended report with correct fei number (3009273792) submitted on 23 march 2016. Infected device - evaluated at hospital.
Patient Sequence No: 1, Text Type: N, H10
[41021014]
Pt presented to er with infected avf ((b)(6) 2016). Redness, swelling, heavy discharge, pain for past 2 days. She said the pain and drainage started a little while after dialysis had accessed the fistula. It got progressively worse until she presented to er. Blood cultures positive. She was taken to surgery the next day and the lower (arterial) v-wing was removed, sent to pathology. It tested (b)(6), as did the blood cultures. She is still hospitalized. Being treated with vancomycin, flagyl, meropenem, and cipro. Has since developed c. Diff and gets a little more confused every day, though ct and mri of brain are negative for ischemia. They have not been able to access the avf successfully yet. Currently dialyzing through femoral access. Avf has palpable thrill and bruit audible, but still have been unsuccessful at cannulating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009273792-2016-00001 |
| MDR Report Key | 5522103 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-24 |
| Date of Report | 2016-02-05 |
| Date of Event | 2016-01-03 |
| Date Mfgr Received | 2016-01-06 |
| Date Added to Maude | 2016-03-24 |
| 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 | 3 |
| Brand Name | VWING VASCULAR NEEDLE GUIDE |
| Generic Name | VWING VASCULAR NEEDLE GUIDE |
| Product Code | PFH |
| Date Received | 2016-03-24 |
| 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. Life Threatening; 3. Required No Informationntervention | 2016-03-24 |