Brand Name | JETSTREAM XC ATHERECTOMY CATHETER |
Type of Device | CATHETER, PERIPHERAL, ATHERECTOMY |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
maple grove MN 55311 |
|
MDR Report Key | 11013296 |
MDR Text Key | 221726369 |
Report Number | 2134265-2020-17838 |
Device Sequence Number | 1 |
Product Code |
MCW
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup,Followup |
Report Date |
01/04/2021 |
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 | 04/18/2022 |
Device Model Number | 45007 |
Device Catalogue Number | 45007 |
Device Lot Number | 0025518093 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
12/13/2020 |
Initial Date FDA Received | 12/15/2020 |
Supplement Dates Manufacturer Received | 12/15/2020 12/15/2020
|
Supplement Dates FDA Received | 12/16/2020 01/04/2021
|
Patient Sequence Number | 1 |
Treatment | NAV 6 EMBOSHEILD, ABBOTT; NAV 6 EMBOSHEILD, ABBOTT |
Patient Outcome(s) |
Other;
Required Intervention;
|
|
|