MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-07-23 for TRAXCESS 7 MINI GW0721006M manufactured by Microvention, Inc..
[80813331]
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 returned for evaluation in its original packaging, without its introducer. Upon investigation, a section of coating came off 146cm from the distal tip. Without the synchro 2 insertion tool used in the procedure, it is unable to confirm if there were any rough edges or burs in the tool which could have caused the coating to come off. The returned guidewire was hydrated and introduced through a new traxcess introducer in which no additional coating came off. Based upon the investigation findings and available information, the reported complaint was confirmed; however, the root cause cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[80813332]
It was reported that the traxcess guidewire was removed from the patient to re-shape the tip. Prior to re-use in the patient, the insertion tool was backloaded onto the guidewire and during the process, the coating appeared to strip off the guidewire. There was no reported patient injury. The patient's current status is reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2017-00173 |
| MDR Report Key | 6735039 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-23 |
| Date of Report | 2017-06-23 |
| Date of Event | 2017-05-11 |
| Date Mfgr Received | 2017-06-23 |
| Device Manufacturer Date | 2017-10-31 |
| Date Added to Maude | 2017-07-23 |
| 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 7 MINI |
| Generic Name | GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2017-07-23 |
| Returned To Mfg | 2017-06-06 |
| Model Number | GW0721006M |
| Lot Number | 17030521 |
| Device Expiration Date | 2019-10-31 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-07-23 |