Brand Name | FEMORAL ARTERIAL CATHETER |
Type of Device | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
EDWARDS LIFESCIENCES |
12050 lone peak parkway |
draper UT 84111 |
|
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 | 4495533 |
MDR Text Key | 20073021 |
Report Number | 3008500478-2015-00013 |
Device Sequence Number | 1 |
Product Code |
DWF
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K123298 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup,Followup |
Report Date |
01/14/2015 |
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 | 05/01/2017 |
Device Model Number | FEMII010A |
Device Lot Number | 59792415 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/18/2015 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/15/2015 |
Initial Date FDA Received | 02/09/2015 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 04/16/2015 05/15/2015
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/12/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | Z-1371-2015 |
Patient Sequence Number | 1 |