FDA Adverse Event
Malfunction
Summary report: N
PENUMBRA SYSTEM REPERFUSION CATHETER 026
MDR report key: 1833896
·
Received September 13, 2010
Report
- Report Number
- 3005168196-2010-00608
- Event Type
- Malfunction
- Date Received
- September 13, 2010
- Date of Event
- August 16, 2010
- Report Date
- August 18, 2010
- Manufacturer
- PENUMBRA, INC.
- Product Code
- NRY
- PMA / PMN Number
- K072718
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. 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
TWO 026 REPERFUSION CATHETERS WHERE OPENED AND UPON EXAMINATION OF BOTH CATHETERS, IT WAS DETERMINED THAT THERE WERE KINKS IN THE CATHETERS DISTAL TO THE HUB, IN THE AREA OF THE BLACK STRAIN RELIEF, RENDERING THE CATHETERS UNUSABLE. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2010-00607.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENUMBRA SYSTEM REPERFUSION CATHETER 026 | PERCUTANEOUS CATHETER | NRY | PENUMBRA, INC. | F16252 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |