Brand Name | ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM |
Type of Device | TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE |
Manufacturer (Section D) |
SILK ROAD MEDICAL INC. |
1213 innsbruck drive |
sunnyvale CA 94089 |
|
Manufacturer (Section G) |
SILK ROAD MEDICAL INC. |
1213 innsbruck drive |
|
sunnyvale CA 94089 |
|
Manufacturer Contact |
yvonne
nguyen
|
1213 innsbruck drive |
sunnyvale, CA 94089
|
4087209002
|
|
MDR Report Key | 15611510 |
MDR Text Key | 301815263 |
Report Number | 3014526664-2022-00160 |
Device Sequence Number | 1 |
Product Code |
NTE
|
UDI-Device Identifier | 00811311020829 |
UDI-Public | (01)00811311020829(17)250526(10)302596 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K153485 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
10/14/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | SR-200-NPS |
Device Catalogue Number | SR-200-NPS |
Device Lot Number | 302596 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/23/2022 |
Initial Date FDA Received | 10/14/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/26/2022 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 72 YR |
Patient Sex | Male |