D
Patient 1
DURING A PROCEDURE THAT INCLUDED THE BETA-RAIL DELIVERY CATHETER, THERE WAS A DISSECTION. PT DEATH OCCURRED.
MAUDE MDR 536598
- MDR report key
- 536598
- Report number
- 1062385-2004-00005
- Event key
- 0
- Event type
- 3
- Date of event
- 2004-07-23
- Date received
- 2004-07-27
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- ANDREW GREEN, VP/QA
- Address
- 3890 STEFE REYNOLDS BLVD. NORCROSS GA 30093 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 3.5 BETA-RAIL DELIVERY CATHETER | CATHETER | NOVOSTE CORP. | MOU | P02561 | ABR-0346 | UNK | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2004-07-27 | 0 | 1. D |