FDA Adverse Event
Malfunction
Summary report: N
PENUMBRA SYSTEM REPERFUSION CATHETER 032
MDR report key: 1900428
·
Received October 26, 2010
Report
- Report Number
- 3005168196-2010-00672
- Event Type
- Malfunction
- Date Received
- October 26, 2010
- Date of Event
- October 19, 2010
- Report Date
- October 20, 2010
- Manufacturer
- PENUMBRA, INC.
- Product Code
- NRY
- PMA / PMN Number
- K072718
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS AVAILABLE FOR EVALUATION AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.
Description of Event or Problem · 1
THE PHYSICIAN USED A PSC032 TO TRACK A PSC054. THE PHYSICIAN THEN REMOVED THE PSC032 FROM THE PSC054 AND PLACED IT ON THE BACK TABLE. WHEN THE CATHETER WAS MOVED TO THE BACK TABLE, IT FELL APART IN TWO PIECES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENUMBRA SYSTEM REPERFUSION CATHETER 032 | PERCUTANEOUS CATHETER | NRY | PENUMBRA, INC. | F15020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |