N
Patient 1
DATE OF EVENT: NO DATE PROVIDED, USED THE FIRST DATE IN THE MONTH OF THE AWARE DATE.
MAUDE MDR 9805583
- MDR report key
- 9805583
- Report number
- 2134265-2020-02656
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-01
- Date received
- 2020-03-09
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JAY JOHNSON
- Address
- TWO SCIMED PLACE MAPLE GROVE MN 55311 US
- Phone
- 763-763-7634
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EXPEL URETERAL STENT SYSTEM | STENT, URETERAL | BOSTON SCIENTIFIC CORPORATION | FAD | 32905 | 32905 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-09 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE METAL TIP SLID OFF. TWO 10FR 28CM NU STENTS WERE SELECTED FOR USE. THE METAL TIP OF THE INTRODUCER SLID OFF BOTH STENT DEVICES AND ONE ENDED UP IN THE PATIENT.