MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-02 for NOVOSTE B-RAIL * ABR-0346 manufactured by Best Vascular, Inc.
[3576289]
The surgeon was unable to correctly deploy brachytherapy catheter (abr-0346) as there was a 'kink' in the catheter. Another catheter had to be used. No impact to the patient. What was the original intended procedure? Catheterization with angiography followed by intravascular brachytherapy due to the proximal and distal stenotic portion of the right femoral popliteal graft. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3225999 |
| MDR Report Key | 3225999 |
| Date Received | 2013-07-02 |
| Date of Report | 2013-07-02 |
| Date of Event | 2013-04-30 |
| Report Date | 2013-07-02 |
| Date Reported to FDA | 2013-07-02 |
| Date Reported to Mfgr | 2013-07-15 |
| Date Added to Maude | 2013-07-15 |
| 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 | 0 |
| 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 | NOVOSTE B-RAIL |
| Generic Name | BRACHY CATHETER |
| Product Code | MOU |
| Date Received | 2013-07-02 |
| Model Number | * |
| Catalog Number | ABR-0346 |
| Lot Number | BW0135 |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEST VASCULAR, INC |
| Manufacturer Address | 4350 INTERNATIONAL BLVD NORCROSS GA 30093 US 30093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-02 |