Brand Name | PRUITT AORTIC OCCLUSION CATHETER |
Type of Device | EMBOLECTOMY CATHETER |
Manufacturer (Section D) |
LEMAITRE VASCULAR, INC. |
63 second ave |
burlington, ma |
|
Manufacturer (Section G) |
LEMAITRE VASCULAR, INC. |
63 second ave |
|
burlington, ma |
|
Manufacturer Contact |
pragya
thikey
|
63 second ave |
burlington, ma
|
2212266152
|
|
MDR Report Key | 9837275 |
MDR Text Key | 197796936 |
Report Number | 1220948-2020-00034 |
Device Sequence Number | 1 |
Product Code |
DQT
|
UDI-Device Identifier | 00840663101511 |
UDI-Public | 00840663101511 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K872090 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/16/2020 |
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 | 07/28/2020 |
Device Model Number | 2100-12 |
Device Catalogue Number | 2100-12 |
Device Lot Number | PAO1158 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/21/2020 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/17/2020 |
Initial Date FDA Received | 03/16/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/15/2015 |
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 |
|
|