MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2003-06-06 for 3.5F BETA-RAIL DELIVERY CATHETER P00563 ABR-0340 manufactured by Novoste Corp..
[273912]
The radioactive sources were left in the pt at the treatment site for a 30 second delay after the intended treatment time. Pt is in stable condition. The site indicated that they were reporting the radiation event to the state.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1062385-2003-00009 |
| MDR Report Key | 465393 |
| Report Source | 05,07 |
| Date Received | 2003-06-06 |
| Date of Report | 2003-06-06 |
| Date of Event | 2003-05-19 |
| Date Mfgr Received | 2003-05-21 |
| Device Manufacturer Date | 2003-01-01 |
| Date Added to Maude | 2003-06-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ADAM LOWE, VP |
| Manufacturer Street | 3890 STEVE REYNOLDS BLVD |
| Manufacturer City | NORCROSS GA 30093 |
| Manufacturer Country | US |
| Manufacturer Postal | 30093 |
| Manufacturer Phone | 7707170904 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5F BETA-RAIL DELIVERY CATHETER |
| Generic Name | CATHETER |
| Product Code | MOU |
| Date Received | 2003-06-06 |
| Model Number | P00563 |
| Catalog Number | ABR-0340 |
| Lot Number | 614298 |
| ID Number | NA |
| Device Expiration Date | 2005-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 454337 |
| Manufacturer | NOVOSTE CORP. |
| Manufacturer Address | 3890 STEVE REYNOLDS BLVD. NORCROSS GA 30093 US |
| Baseline Brand Name | BETA-RAIL 35F DELIVERY CATHETER |
| Baseline Generic Name | CATHETER |
| Baseline Model No | P00563 |
| Baseline Catalog No | ABR-0340 |
| Baseline ID | NA |
| Baseline Device Family | BETA-RAIL 3.5F DELIVERY CATHETER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | Y |
| Premarket Approval | P0000 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-06-06 |