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 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
model farm road |
|
cork |
EI
|
|
Manufacturer Contact |
jay
johnson
|
4100 hamline ave n |
arden hills, MN 55112
|
6515810888
|
|
MDR Report Key | 16017187 |
MDR Text Key | 307936906 |
Report Number | 2124215-2022-53925 |
Device Sequence Number | 1 |
Product Code |
MCW
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/20/2022 |
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 Model Number | 45007 |
Device Catalogue Number | 45007 |
Device Lot Number | 0030293614 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/15/2022
|
Initial Date FDA Received | 12/20/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/06/2022 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |