FDA Adverse Event
Malfunction
Summary report: N
PENUMBRA SYSTEM REPERFUSION CATHETER 041
MDR report key: 1930322
·
Received November 18, 2010
Report
- Report Number
- 3005168196-2010-00685
- Event Type
- Malfunction
- Date Received
- November 18, 2010
- Date of Event
- October 27, 2010
- Report Date
- October 29, 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
Narratives
Additional Manufacturer Narrative · 1
DEVICE INVESTIGATION: THERE IS A KINK 26.7 CM FROM THE HUB SHAFT JOINT IN THE PROXIMAL SECTION OF THE SHAFT. A 0.041" MANDREL WAS INTRODUCED INTO THE HUB AND ADVANCED. THE MANDREL STOPPED 26.6 CM FROM THE HUB SHAFT JOINT. THE CATHETER IS NON-FUNCTIONAL. CONCLUSION: THE DAMAGE OBSERVED AGREES WITH THE DESCRIPTION IN THE COMPLAINT. THIS TYPE OF DAMAGE CAN RESULT FROM IMPROPER HANDLING DURING REMOVAL FROM THE CARRYING HOOP.
Description of Event or Problem · 1
THE SITE DISCOVERED A CRIMP IN THE DISTAL END OF THE PENUMBRA SYSTEM REPERFUSION CATHETER 041 UPON OPENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENUMBRA SYSTEM REPERFUSION CATHETER 041 | PERCUTANEOUS CATHETER | NRY | PENUMBRA INC. | F15795 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |