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 2018-08-29 for TRAXCESS UNKNOWN manufactured by Microvention, Inc..
[118613774]
The lot number was not provided; therefore, the device history records could not be reviewed. The device was discarded at the user facility and not returned for evaluation; therefore, a product analysis could not be performed. The root cause cannot be determined. The instructions for use (ifu) identifies vessel perforation and intracerebral hemorrhage as potential complications associated with use of the device.
Patient Sequence No: 1, Text Type: N, H10
[118613775]
It was reported that a patient was being treated for an acute arteriovenous malformation (avm), located at the superior cerebellar artery (sca), with three (3) intranidal aneurysms. Via the basilar artery, the traxcess wire passed the 1st aneurysm to access the 3rd aneurysm via the 2nd aneurysm; however, the 2nd aneurysm ruptured. Embolization coils were immediately deployed to occlude the sca, which slowed the rupture; however, did not stop the bleeding completely. The patient's pupils were checked and noted to be fixed dilated. The patient was taken for surgical placement of an external ventricular drain (evd). The patient was reported to be unstable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2018-00175 |
| MDR Report Key | 7827506 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-01 |
| Date of Event | 2018-08-01 |
| Date Mfgr Received | 2018-08-01 |
| Date Added to Maude | 2018-08-29 |
| 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 |
| Generic Name | GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2018-08-29 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| 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 | 1. Life Threatening; 2. Required No Informationntervention | 2018-08-29 |