Brand Name | POLARSHEATH |
Manufacturer (Section D) |
BOSTON SCIENTIFIC DE COSTA RICA S.R.L. |
302 parkway |
global park, la aurora |
heredia |
CS |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC DE COSTA RICA S.R.L. |
302 parkway, global park |
|
la aurora, heredia |
CS
|
|
Manufacturer Contact |
timothy
degroot
|
4100 hamline avenue north |
dc a330 |
saint paul, MN 55112
|
6515826168
|
|
MDR Report Key | 15300830 |
MDR Text Key | 298708258 |
Report Number | 2134265-2022-08686 |
Device Sequence Number | 1 |
Product Code |
DRA
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
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 |
08/26/2022 |
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 |
08/02/2022 |
Initial Date FDA Received | 08/26/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | POLARMAP; POLARX |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Male |
|
|