MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-02 for B-RAIL * manufactured by Best Vascular, Inc..
[18093490]
Novoste b-rail inserted by the interventional cardiologist into circumflex artery for intra-coronary radiation therapy treatment. Radiation seeds would not deliver through catheter, catheter was removed and a second device used without issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4507759 |
| MDR Report Key | 4507759 |
| Date Received | 2015-02-02 |
| Date of Report | 2015-02-02 |
| Date of Event | 2015-01-29 |
| Report Date | 2015-02-02 |
| Date Reported to FDA | 2015-02-02 |
| Date Reported to Mfgr | 2015-02-11 |
| Date Added to Maude | 2015-02-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | B-RAIL |
| Generic Name | INTRAVASCULAR RADIATION DELIVERY SYSTEM |
| Product Code | MOU |
| Date Received | 2015-02-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | BW0138 |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEST VASCULAR, INC. |
| Manufacturer Address | 4350 INTERNATIONAL BOULEVARD, NORCROSS GA 30093 US 30093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-02 |