MAUDE MDR 50941445
- MDR report key
- 50941445
- Report number
- 3013300026-2026-03209
- Event key
- 0
- Event type
- 3
- Date of event
- 2026-09-01
- Date received
- 2026-09-30
- Adverse event
- 0
- Product problem
- 1
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 87403 | SMARTABLATE | Cardiac Ablation Percutaneous Catheter | Biosense Webster Inc | LPB | | SAT001 | 3017531 | | | | N | N |
| 418197 | SMARTABLATE | Cardiac Ablation Percutaneous Catheter | Biosense Webster Inc | LPB | | SAT001 | 3017531 | | | | N | N |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2026-09-30 | 0 | |
Event Narratives#
No narrative records found.