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 2017-06-10 for TRAXCESS 14 SELECT GW1420040S manufactured by Microvention, Inc..
[77271720]
The lot number was provided. A review of the approved device history records indicated the lot met all release criteria. A lot history trending review was performed and there were no similar complaints for this lot number. The device was discarded at the user facility; therefore, a product analysis could not be performed. There was no reported device malfunction. The root cause cannot be determined. The instructions for use (ifu) identifies vessel perforation, intracerebral hemorrhage, and death as potential complications associated with use of the device. Additionally, the ifu warns to manipulate the guidewire under fluoroscopic guidance.
Patient Sequence No: 1, Text Type: N, H10
[77271721]
It was reported that during embolization treatment of an aneurysm, "the doctor punched an artery" and a hemorrhagic event was observed a few seconds after. It was reported that the x-ray didn't work while the wire was advanced. The patient was reported to have died. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2017-00139 |
| MDR Report Key | 6632837 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-06-10 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-03-31 |
| Date Mfgr Received | 2017-05-11 |
| Device Manufacturer Date | 2016-10-31 |
| Date Added to Maude | 2017-06-10 |
| 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 | 1311 VALENCIA AVENUE |
| Manufacturer City | TUSTIN CA 92780 |
| Manufacturer Country | US |
| Manufacturer Postal | 92780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRAXCESS 14 SELECT |
| Generic Name | GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2017-06-10 |
| Model Number | GW1420040S |
| Lot Number | 16111130 |
| Device Expiration Date | 2019-10-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROVENTION, INC. |
| Manufacturer Address | 1311 VALENCIA AVENUE TUSTIN CA 92780 US 92780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-06-10 |