FDA Adverse Event
Malfunction
Summary report: N
PENUMBRA SYSTEM SEPARATOR 054
MDR report key: 1930336
·
Received November 18, 2010
Report
- Report Number
- 3005168196-2010-00681
- Event Type
- Malfunction
- Date Received
- November 18, 2010
- Date of Event
- October 24, 2010
- Report Date
- October 25, 2010
- Manufacturer
- PENUMBRA INC.
- Product Code
- NRY
- PMA / PMN Number
- K090752
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.
Description of Event or Problem · 1
A PSC054 WAS ADVANCED TO THE PROXIMAL PORTION OF AN ICA OCCLUSION. A PSS054 WAS ADVANCED BUT WAS UNABLE TO TRACK THROUGH THE CATHETER AND WAS DAMAGED. THIS THEN HAPPENED TO A SECOND SEPARATOR. A THIRD SEPARATOR WAS INTRODUCED AND ADVANCED SMOOTHLY AND NAVIGATED INTO POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENUMBRA SYSTEM SEPARATOR 054 | PERCUTANEOUS CATHETER | NRY | PENUMBRA INC. | F16983 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |