Brand Name | ANGIOJET |
Type of Device | CATHETER, CORONARY, ATHERECTOMY |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
maple grove MN 55311 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
|
maple grove MN 55311 |
|
Manufacturer Contact |
jay
johnson
|
4100 hamline ave n |
arden hills, MN 55112
|
6515810888
|
|
MDR Report Key | 15245081 |
MDR Text Key | 298112563 |
Report Number | 2134265-2022-08439 |
Device Sequence Number | 1 |
Product Code |
MCX
|
Combination Product (y/n) | N |
Reporter Country Code | SP |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
08/17/2022 |
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
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/28/2022 |
Initial Date FDA Received | 08/17/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 54 YR |
Patient Sex | Male |