Brand Name | POLARSHEATH |
Type of Device | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
Manufacturer (Section D) |
BOSTON SCIENTIFIC DE COSTA RICA S.R.L. |
302 parkway |
global park, la aurora |
heredia |
CS |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
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 | 10726841 |
MDR Text Key | 212733570 |
Report Number | 2134265-2020-14693 |
Device Sequence Number | 1 |
Product Code |
DRA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,study |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
10/23/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/23/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/22/2021 |
Device Model Number | M004CRBSUSC3050 |
Device Lot Number | 0025586327 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 10/15/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/11/2020 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Treatment | POLARX CRYOABLATION CATHETER |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 74 YR |
Patient Weight | 83 |