Brand Name | FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER |
Type of Device | FOGARTY THRU-LUMEN EMBOLECTOMY |
Manufacturer (Section D) |
EDWARDS LIFESCIENCES, PR |
state rd indus pk 402 km 1.4 |
anasco PR 00610 |
|
Manufacturer (Section G) |
EDWARDS LIFESCIENCES, PR |
state rd indus pk 402 km 1.4 |
|
anasco PR 00610 |
|
Manufacturer Contact |
jonathan
diaz
|
1 edwards way |
irvine, CA 92614
|
9492507258
|
|
MDR Report Key | 16338588 |
MDR Text Key | 309194464 |
Report Number | 2015691-2023-10703 |
Device Sequence Number | 1 |
Product Code |
DXE
|
UDI-Device Identifier | 00690103043532 |
UDI-Public | (01)00690103043532(17)240114(11)211015(10)64036596 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K892410 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Consumer,User Facility,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/14/2023 |
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 | 01/14/2024 |
Device Model Number | 12TLW805F35 |
Device Catalogue Number | 12TLW805F35 |
Device Lot Number | 64036596 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/19/2023 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/23/2023
|
Initial Date FDA Received | 02/09/2023 |
Supplement Dates Manufacturer Received | 03/10/2023
|
Supplement Dates FDA Received | 03/14/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/16/2021 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |