FDA Adverse Event
Malfunction
Summary report: N
NEURON DELIVERY CATHETER 070
MDR report key: 1950410
·
Received December 14, 2010
Report
- Report Number
- 3005168196-2010-00702
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Report Date
- November 23, 2010
- Manufacturer
- PENUMBRA, INC.
- Product Code
- DQY
- PMA / PMN Number
- K082290
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR EVAL. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED.
Description of Event or Problem · 1
THE HOSPITAL DISCOVERED THAT TWO NEURONS HAD SMASHED TIPS WHEN THE PACKAGES WERE OPENED. THE NEURONS WERE NOT USED IN THE CASE. ANOTHER DEVICE WAS AVAILABLE AND USED TO COMPLETE THE CASE. THIS MDR IS ASSOCIATED WITH MDR #: 3005168196-2010-00703.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEURON DELIVERY CATHETER 070 | PERCUTANEOUS CATHETER | DQY | PENUMBRA, INC. | F16213 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |