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 2017-11-17 for TRAXCESS 14 GUIDEWIRE (14 IN.) GW1420040 manufactured by Microvention, Inc..
[93094098]
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.
Patient Sequence No: 1, Text Type: N, H10
[93094099]
It was reported that the physician performed a "test" of the guidewire without any intention of using it in the patient. The wire was removed from the dispenser and introduced into the inlet guide. The inlet guide was advanced over the wire, keeping the wire straight. The inlet guide was pulled back and removed from the wire. After removal, the wire was inspected, and coating residuals on the wire appeared to be "scraped off. " there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2017-00290 |
| MDR Report Key | 7041822 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-17 |
| Date of Report | 2017-10-19 |
| Date of Event | 2017-10-11 |
| Date Mfgr Received | 2017-10-19 |
| Device Manufacturer Date | 2017-07-31 |
| Date Added to Maude | 2017-11-17 |
| 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 | 2017-11-17 |
| Returned To Mfg | 2017-10-30 |
| Model Number | GW1420040 |
| Lot Number | 170802 |
| 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 | 2017-11-17 |