Brand Name | COMET II |
Type of Device | TRANSDUCER, PRESSURE, CATHETER TIP |
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 | 16432380 |
MDR Text Key | 310107384 |
Report Number | 2124215-2023-08187 |
Device Sequence Number | 1 |
Product Code |
DXO
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/23/2023 |
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 Model Number | 2404-02 |
Device Catalogue Number | 2404-02 |
Device Lot Number | 0030208162 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/20/2023
|
Initial Date FDA Received | 02/23/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/23/2022 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|