MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2003-09-18 for 3.5F BETA-RAIL DELIVERY CATHETER ABR-0340 UNK manufactured by Novoste Corp.
[19902454]
Pt death. Complainant reported that angiomax was used with vascular bradytherapy treatment. Complainant reported that the pt was treated for two radiation segments for a total of 7 minute treatment time. Pt developed a thrombus formation immediately following the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1062385-2003-00012 |
| MDR Report Key | 484645 |
| Report Source | 05,07 |
| Date Received | 2003-09-18 |
| Date of Report | 2003-09-18 |
| Date of Event | 2003-08-18 |
| Date Mfgr Received | 2003-08-18 |
| Date Added to Maude | 2003-09-25 |
| 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 | 2003-09-18 |
| Model Number | ABR-0340 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 473536 |
| Manufacturer | NOVOSTE CORP |
| Manufacturer Address | 3890 STEVE REYNOLDS BLVD NORCROSS GA 30093 US |
| Baseline Brand Name | 3.5F BETA-RAIL (TM) DELIVERY CATHETER |
| Baseline Generic Name | CATHETER |
| Baseline Model No | ABR-0340 |
| Baseline Catalog No | UNK |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2003-09-18 |