FDA Adverse Event
Malfunction
Summary report: N
PENUMBRA COIL 400
MDR report key: 3944201
·
Received July 18, 2014
Report
- Report Number
- 3005168196-2014-00462
- Event Type
- Malfunction
- Date Received
- July 18, 2014
- Date of Event
- June 17, 2014
- Report Date
- June 20, 2014
- Manufacturer
- PENUMBRA, INC.
- Product Code
- HCG
- PMA / PMN Number
- K120330
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: 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. THE HOSPITAL DISPOSED OF THE DEVICE.
Description of Event or Problem · 1
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING THE PENUMBRA COIL 400 SYSTEM. BEFORE THE PROCEDURE, THE PENUMBRA COIL 400 BECAME KINKED WHILE REMOVING IT FROM ITS PACKAGING. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422381 | PENUMBRA COIL 400 | HCG, KRD | HCG | PENUMBRA, INC. | F22050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |