MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-03-24 for VWING VASCULAR NEEDLE GUIDE 00146 manufactured by Vital Access Corp..
[41033514]
Still implanted - removal scheduled.
Patient Sequence No: 1, Text Type: N, H10
[41033515]
Patient (b)(6) had a scab over their arterial access site, which showed pus once removed. A blood culture was negative, but a skin culture at the site showed klebsiella pneumoniae. Patient received antibiotics (ancef) but refused to receive a central venous catheter during healing. Cannulations of the patient's fistula are continuing outide of the vwing sites. Vwing devices are scheduled to be removed.
Patient Sequence No: 1, Text Type: D, B5
[41432381]
Patient kw had a scab over their arterial access site, which showed pus once removed. A blood culture was (b)(6), but a skin culture at the site showed klebsiella pneumoniae. Patient received antibiotics (ancef) but refused to receive a central venous catheter during healing. Cannulations of the patient's fistula are continuing outside of the vwing sites. Initially, the company was informed that the vwing devices were scheduled to be removed. Upon seeing the patient, the implanting surgeon was able to further diagnose the patient. While the patient did have a cannulation-related infection, this infection was determined to be separate from the vwing devices. The patient was diagnosed with an infected hematoma. The vwing devices were both left in place in the patient while the hematoma healed. The company has been informed that the patient is now being cannulated successfully through their vwing devices again. No vwing-related serious adverse event occurred. Devices not removed - not infected.
Patient Sequence No: 1, Text Type: N, H10
[41432382]
Patient kw had a scab over their arterial access site, which showed pus once removed. A blood culture was (b)(6), but a skin culture at the site showed klebsiella pneumoniae. Patient received antibiotics (ancef) but refused to receive a central venous catheter during healing. Cannulations of the patient's fistula are continuing outside of the vwing sites. Initially, the company was informed that the vwing devices were scheduled to be removed. Upon seeing the patient, the implanting surgeon was able to further diagnose the patient. While the patient did have a cannulation-related infection, this infection was determined to be separate from the vwing devices. The patient was diagnosed with an infected hematoma. The vwing devices were both left in place in the patient while the hematoma healed. The company has been informed that the patient is now being cannulated successfully through their vwing devices again. No vwing-related serious adverse event occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009273792-2015-00002 |
| MDR Report Key | 5522440 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-03-24 |
| Date of Report | 2016-03-30 |
| Date of Event | 2015-11-18 |
| Date Mfgr Received | 2015-11-30 |
| Device Manufacturer Date | 2015-03-15 |
| 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 |
| Product Code | PFH |
| Date Received | 2016-03-24 |
| Model Number | 00146 |
| Lot Number | 15-0032 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-03-24 |