MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-24 for VWNG 8MM 171 manufactured by Vital Access.
[19563113]
Pt was part of a clinical trial of venous window needle guide implanted under ide on (b)(6) 2011. The needle guide was difficult to cannulate and pt requested it be removed (b)(6) 2013. Only 10 degrees angulation. Device well-incorporated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030438 |
| MDR Report Key | 3151696 |
| Date Received | 2013-05-24 |
| Date of Report | 2013-05-15 |
| Date of Event | 2013-05-15 |
| Date Added to Maude | 2014-06-24 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VWNG |
| Generic Name | VENOUS WINDOW NEEDLE GUIDE |
| Product Code | PFH |
| Date Received | 2013-05-24 |
| Returned To Mfg | 2013-05-28 |
| Model Number | 8MM |
| Catalog Number | 171 |
| Lot Number | 110093 |
| Device Expiration Date | 2013-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VITAL ACCESS |
| Manufacturer Address | SALT LAKE CITY UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-24 |