Brand Name | SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP |
Type of Device | EMBOLECTOMY CATHETER - REGULAR TIP |
Manufacturer (Section D) |
LEMAITRE VASCULAR, INC. |
63 second ave |
burlington MA 01803 |
|
Manufacturer (Section G) |
LEMAITRE VASCULAR, INC |
63 second ave |
|
burlington MA 01803 |
|
Manufacturer Contact |
peter
song
|
63 second ave |
burlington, MA 01803
|
7814251683
|
|
MDR Report Key | 18575632 |
MDR Text Key | 334031787 |
Report Number | 1220948-2024-00021 |
Device Sequence Number | 1 |
Product Code |
DXE
|
UDI-Device Identifier | 00840663100927 |
UDI-Public | (01)00840663100927 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K992368 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
01/24/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/24/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 1801-48 |
Device Lot Number | NSE2664 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/22/2024 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/25/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/21/2022 |
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 |