MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-22 for TRAXCESS 14 SELECT GW1420040S manufactured by Microvention, Inc..
[73454424]
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
[73454425]
It was reported that during treatment for spasmolysis in the right internal carotid artery (ica), the wire perforated the ica, resulting in interhemispherical bleeding above the corpus callosum. The patient was reported to be on ass and plavix (dual antiplatelet therapy) due to recent implantation of a flow diverter in the ica. No intervention was performed to address the bleeding at the time of the procedure. The patient remains ventilated and cannot breathe alone; it is unclear how long the patient will need assisted ventilation. At this time, it is unknown if the patient has sustained any permanent injury or impairment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2017-00098 |
| MDR Report Key | 6514322 |
| Date Received | 2017-04-22 |
| Date of Report | 2017-03-23 |
| Date of Event | 2017-03-22 |
| Date Mfgr Received | 2017-03-23 |
| Device Manufacturer Date | 2016-10-31 |
| Date Added to Maude | 2017-04-22 |
| 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 |
| Manufacturer Phone | 7142478000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRAXCESS 14 SELECT |
| Generic Name | GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2017-04-22 |
| Model Number | GW1420040S |
| Lot Number | 16110825 |
| Device Expiration Date | 2019-10-31 |
| Operator | PHYSICIAN |
| 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. Hospitalization; 2. Life Threatening | 2017-04-22 |