Brand Name | ENROUTE NEUROPROTECTION SYSTEM |
Type of Device | TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE |
Manufacturer (Section D) |
SILK ROAD MEDICAL, INC. |
1213 innsbruck dr. |
sunnyvale CA 94089 |
|
Manufacturer (Section G) |
SILK ROAD MEDICAL, INC. |
1213 innsbruck drive |
|
sunnyvale CA 94089 |
|
Manufacturer Contact |
|
1213 innsbruck dr. |
sunnyvale, CA 94089
|
|
MDR Report Key | 9649341 |
MDR Text Key | 179311957 |
Report Number | 3014526664-2020-00012 |
Device Sequence Number | 1 |
Product Code |
NTE
|
UDI-Device Identifier | 00811311020829 |
UDI-Public | (01)00811311020829(17)180831(10)200960 |
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 |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
01/30/2020 |
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 Expiration Date | 08/31/2018 |
Device Model Number | SR-200-NPS |
Device Catalogue Number | SR-200-NPS |
Device Lot Number | 200960 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/09/2017
|
Initial Date FDA Received | 01/30/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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) |
Other;
Disability;
|