FDA Adverse Event
Malfunction
Summary report: N
NEURON DELIVERY CATHETER 053
MDR report key: 1642400
·
Received March 16, 2010
Report
- Report Number
- 3005168196-2010-00420
- Event Type
- Malfunction
- Date Received
- March 16, 2010
- Date of Event
- December 1, 2009
- Report Date
- December 1, 2009
- Manufacturer
- PENUMBRA, INC.
- Product Code
- DQY
- PMA / PMN Number
- K070970
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TECHNICAL EVALUATION: ONLY DEVICE #1 WAS RETURNED. AT THE DISTAL TIP, THERE IS AN OVALIZATION BETWEEN 0.7 AND 1.0CM. A 0.053" MANDREL ENCOUNTERS RESISTANCE AT THE OVALIZATION BUT PASSES WITHOUT EXCESSIVE FORCE. CONCLUSION: THE INCIDENT IS CONFIRMED AS REPORTED. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA FEBRUARY 2010 UPDATE TO THE FDA WARNING LETTER DATED DECEMBER 31, 2009.
Description of Event or Problem · 1
THE CUSTOMER HAD TWO INSTANCES WHERE THEY HAD TO THROW THE CATHETER AWAY DUE TO KINKING; NOTICED AS IT WAS REMOVED FROM THE PACKAGE. ADDITIONAL CATALOG #: PND6F0701058M, ADDITIONAL 510 (K): K082290.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEURON DELIVERY CATHETER 053 | PERCUTANEOUS CATHETER | DQY | PENUMBRA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |