MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-12 for NOVOSTE BETA-CATH IVB NOVOSTE 40 MM * manufactured by Best Vascular, Inc.
[19416760]
When the system was engaged to return the radiation sources, the sources did not immediately return as expected. The sources were stuck in the area of the aorta. There was an approximately a 1 minute delay while the entire system was removed to prevent continued exposure. This has happened before with the device. What was the original intended procedure? Vascular brachytherapy. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3208703 |
| MDR Report Key | 3208703 |
| Date Received | 2013-06-12 |
| Date of Report | 2013-06-12 |
| Date of Event | 2013-06-03 |
| Report Date | 2013-06-12 |
| Date Reported to FDA | 2013-06-12 |
| Date Reported to Mfgr | 2013-07-08 |
| Date Added to Maude | 2013-07-08 |
| 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 |
| 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 BETA-CATH IVB |
| Generic Name | DEVICE, INTRAVASCULAR BRACHYTHERAPY |
| Product Code | MOU |
| Date Received | 2013-06-12 |
| Returned To Mfg | 2013-06-12 |
| Model Number | NOVOSTE 40 MM |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | * |
| 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 | 2013-06-12 |