FDA Adverse Event
Malfunction
Summary report: N
NEURON DELIVERY CATHETER 070
MDR report key: 2093360
·
Received April 19, 2011
Report
- Report Number
- 3005168196-2011-00153
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 25, 2011
- Manufacturer
- PENUMBRA, INC.
- Product Code
- DQY
- PMA / PMN Number
- K082290
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS AVAILABLE FOR RETURN AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.
Description of Event or Problem · 1
THE PHYSICIAN ATTEMPTED TO INSERT THE PENUMBRA NEURON DELIVERY CATHETER 070 INTO THE 6F TERUMO GROIN SHEATH USING THE NEURON INTRODUCER. THE NEURON DID NOT EASILY PASS THROUGH THE VALVE ON THE SHEATH AND KINKED. AN ALTERNATE NEURON 070 STR CATHETER WAS SELECTED AND THE SAME SITUATION OCCURRED. THE PHYSICIAN THEN SELECTED A 6F ENVOY CATHETER AND COMPLETED THE CASE WITH THAT CATHETER. NO PATIENT INJURY WAS REPORTED. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2011-00154.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEURON DELIVERY CATHETER 070 | DQY | PENUMBRA, INC. | F17848 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |