D
Patient 1
COMPLAINANT REPORTED THAT THE BETA-RAIL 3.5F DELIVERY CATHETER GOT CAUGHT ON THE GUIDE CATHETER DURING REMOVAL. THE BETA-RAIL CATHETER WAS REMOVED; HOWEVER, IT WAS DAMAGED IN THE PROCESS.
MAUDE MDR 396099
- MDR report key
- 396099
- Report number
- 1062385-2002-00019
- Event key
- 0
- Event type
- 3
- Date of event
- 2002-04-18
- Date received
- 2002-05-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- ADAM LOWE, VP, RA/QA
- Address
- 3890 STEVE 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 | BETA-RAIL 3.5F DELIVERY CATHETER | CATHETER | NOVOSTE CORP. | MOU | P00563 | ABR-0340 | UNK | P0000 | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2002-05-17 | 0 |