Brand Name | WATCHMAN TRUSEAL ACCESS SYSTEM |
Type of Device | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
maple grove MN 55311 |
|
MDR Report Key | 10328471 |
MDR Text Key | 200606299 |
Report Number | 2134265-2020-09732 |
Device Sequence Number | 1 |
Product Code |
DQY
|
UDI-Device Identifier | 08714729965718 |
UDI-Public | 08714729965718 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
09/01/2020 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/18/2022 |
Device Model Number | M635TU70020 |
Device Catalogue Number | M635TU70020 |
Device Lot Number | 0024795192 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/06/2020 |
Initial Date FDA Received | 07/27/2020 |
Supplement Dates Manufacturer Received | 08/10/2020
|
Supplement Dates FDA Received | 09/01/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|