Brand Name | ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER |
Type of Device | PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION |
Manufacturer (Section D) |
MEDTRONIC CRYOCATH LP |
9000 autoroute transcanadienne |
pointe-claire,qc H9R 5 Z8 |
CA H9R 5Z8 |
|
Manufacturer (Section G) |
MEDTRONIC CRYOCATH LP |
9000 autoroute transcanadienne |
|
pointe-claire,qc H9R 5 Z8 |
CA
H9R 5Z8
|
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 9176801 |
MDR Text Key | 162486445 |
Report Number | 3002648230-2019-00697 |
Device Sequence Number | 1 |
Product Code |
OAE
|
UDI-Device Identifier | 00643169976382 |
UDI-Public | 00643169976382 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P100010/S015 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
10/10/2019 |
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 Expiration Date | 03/21/2020 |
Device Model Number | 2AF284 |
Device Catalogue Number | 2AF284 |
Device Lot Number | 44473 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/19/2019
|
Initial Date FDA Received | 10/10/2019 |
Date Device Manufactured | 03/22/2019 |
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 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 65 YR |
Patient Weight | 189 |