Brand Name | ANTEGRADE CARDIOPLEGIA CANNULA |
Type of Device | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
EDWARDS LIFESCIENCES |
12050 lone peak parkway |
draper UT 84020 |
|
Manufacturer (Section G) |
EDWARDS LIFESCIENCES LLC |
12050 lone peak parkway |
|
draper UT 84020 |
|
Manufacturer Contact |
walt
wiegand
|
12050 lone peak parkway |
draper, UT 84020
|
8015655200
|
|
MDR Report Key | 3630764 |
MDR Text Key | 3986401 |
Report Number | 3008500478-2014-00026 |
Device Sequence Number | 1 |
Product Code |
DWF
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K113459 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Invalid Data |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
01/30/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/01/2016 |
Device Model Number | ATC011MV |
Device Lot Number | 59615859 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/12/2014 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 01/30/2014 |
Device Age | 2 MO |
Date Report to Manufacturer | 01/30/2014 |
Initial Date Manufacturer Received |
01/30/2014 |
Initial Date FDA Received | 02/17/2014 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 04/24/2014
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |