Brand Name | SYMMETRY |
Type of Device | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
maple grove MN 55311 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
ballybrit business park |
|
galway |
EI
|
|
Manufacturer Contact |
jay
johnson
|
two scimed place |
maple grove, MN 55311
|
7634942574
|
|
MDR Report Key | 9995825 |
MDR Text Key | 189031056 |
Report Number | 2134265-2020-04768 |
Device Sequence Number | 1 |
Product Code |
LIT
|
UDI-Device Identifier | 08714729181958 |
UDI-Public | 08714729181958 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K143193 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/24/2020 |
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 | 04/23/2022 |
Device Model Number | 23295 |
Device Catalogue Number | 23295 |
Device Lot Number | 0023689897 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/18/2020 |
Initial Date Manufacturer Received |
04/02/2020 |
Initial Date FDA Received | 04/24/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/24/2019 |
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 |