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..
[92622985]
The lot number was provided. A review of the approved device history records indicated the lot met all release criteria. The device has been returned for evaluation. The investigation is currently underway. The device was used during the same procedure as was reported in mfr report# 2032493-2017-00279.
Patient Sequence No: 1, Text Type: N, H10
[92622986]
It was reported that an interventional procedure was performed in a peripheral (forearm) vessel. After the traxcess guidewire was removed from the microcatheter (another manufacturer's device), the wire was wiped with a compress to prepare it for later use during the procedure. Upon examination of the wire after it had been wiped, it appeared that the coating was missing from two sections of the wire, and a "black color" was seen in the compress. Additionally, the coating from the wire came off when the torque device was removed. There was no reported patient injury and the current patient's status is reported to be "fine. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2017-00278 |
| MDR Report Key | 7022816 |
| 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 |
| Returned To Mfg | 2017-10-27 |
| Model Number | GW1420040 |
| Lot Number | 170731 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |