Brand Name | LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT |
Type of Device | BALLOON EXPANDABLE VASCULAR COVERED STENT |
Manufacturer (Section D) |
CLEARSTREAM TECHNOLOGIES LTD. |
moyne upper |
enniscorthy, co. wexford N A |
EI N A |
|
Manufacturer (Section G) |
CLEARSTREAM TECHNOLOGIES LTD. |
moyne upper |
|
enniscorthy, co. wexford N A |
EI
N A
|
|
Manufacturer Contact |
judith
ludwig
|
1415 w. 3rd street |
tempe, AZ 85281
|
4803032689
|
|
MDR Report Key | 9404470 |
MDR Text Key | 190034406 |
Report Number | 9616666-2019-00148 |
Device Sequence Number | 1 |
Product Code |
PRL
|
UDI-Device Identifier | 05391522081765 |
UDI-Public | (01)05391522081765 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P160024 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/03/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/03/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/30/2022 |
Device Catalogue Number | LSM1351238 |
Device Lot Number | CMDU0072 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/14/2019 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 11/11/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/03/2019 |
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 Age | 68 YR |
Patient Weight | 80 |