N
Patient 1
THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.
MAUDE MDR 9892266
- MDR report key
- 9892266
- Report number
- 3005168196-2020-00462
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-06
- Date received
- 2020-03-27
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. VERONICA FARRIS
- Address
- ONE PENUMBRA PLACE ALAMEDA CA 94502 US
- Phone
- 510-510-5107
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LANTERN DELIVERY MICROCATHETER | DQY | PENUMBRA, INC. | DQY | PXSLIMLAN150STR | PXSLIMLAN150STR | F94074 | Y | ||||
| 101 | --- |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-27 | 0 |
Event Narratives#
D
Patient 1
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, WITH THE LANTERN ADVANCED IN THE DIAGNOSTIC CATHETER, THE LANTERN BROKE MID-SHAFT AT THE PROXIMAL END OF THE DIAGNOSTIC CATHETER. THEREFORE, THE PHYSICIAN USED A TWEEZER TO REMOVE THE BROKEN LANTERN OUT OF THE DIAGNOSTIC CATHETER. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER AND THE SAME DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.