MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-10 for TRAXCESS 14 GUIDEWIRE (14 IN.) GW1420040 manufactured by Microvention, Inc..
[92733450]
The lot number was provided. A review of the approved device history records indicated the lot met all release criteria. The device was discarded at the user facility and will not be returned for evaluation; therefore, a product analysis will not be performed. The root cause cannot be determined. The device was used during the same procedure as was reported in mfr report# 2032493-2017-00278.
Patient Sequence No: 1, Text Type: N, H10
[92733611]
It was reported that the coating appeared to come off the guide wire. The device was being used for an interventional procedure in a peripheral (forearm) vessel. It is unknown when the issue was discovered. There was no reported patient injury and the current patient's status was reported to be "fine. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2017-00279 |
| MDR Report Key | 7022877 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-10 |
| Date of Report | 2017-10-11 |
| Date of Event | 2017-10-11 |
| Date Mfgr Received | 2017-10-11 |
| Device Manufacturer Date | 2017-06-30 |
| Date Added to Maude | 2017-11-10 |
| 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 | MS. DEBBY CALLAHAN |
| Manufacturer Street | 35 ENTERPRISE DRIVE |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRAXCESS 14 GUIDEWIRE (14 IN.) |
| Generic Name | GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2017-11-10 |
| Model Number | GW1420040 |
| Lot Number | 170731 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROVENTION, INC. |
| Manufacturer Address | 35 ENTERPRISE DRIVE ALISO VIEJO CA 92656 US 92656 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-10 |