FDA Adverse Event
Malfunction
Summary report: N
NEURON DELIVERY CATHETER 053
MDR report key: 2093181
·
Received April 14, 2011
Report
- Report Number
- 3005168196-2011-00147
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Report Date
- March 17, 2011
- Manufacturer
- PENUMBRA, INC.
- Product Code
- DQY
- PMA / PMN Number
- K070970
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN AND A F/U MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.
Description of Event or Problem · 1
A NEURON DELIVERY CATHETER 053 WAS FOUND TO BE DAMAGED UPON REMOVAL FROM THE PACKAGE. THE DEVICE WAS KINKED AT THE DISTAL PORTION NEAR THE TIP. THE DEVICE WAS NOT USED. A SECOND DEVICE WAS USED, AND THE PHYSICIAN COMPLETED THE CASE SUCCESSFULLY. NO DATE OF EVENT WAS PROVIDED, AS A HOSP REP WAS HOLDING THE PRODUCT IN HER OFFICE FOR SOME TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEURON DELIVERY CATHETER 053 | DQY | PENUMBRA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |