Brand Name | TACTICATH QUARTZ CONTACT FORCE ABLATION CATHETER, 65MM |
Type of Device | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION |
Manufacturer (Section D) |
VENUSA DE MEXICO S.A. DE C.V. |
calle hertz 1525-6 |
parque industrial j. bermudez |
ciudad juarez, chihuahua 32470 |
MX 32470 |
|
Manufacturer (Section G) |
VENUSA DE MEXICO S.A. DE C.V. |
calle hertz 1525-6 |
parque industrial j. bermudez |
ciudad juarez, chihuahua 32470 |
MX
32470
|
|
Manufacturer Contact |
janna
parks
|
5050 nathan lane north |
plymouth, MN 55442
|
6517565400
|
|
MDR Report Key | 12302475 |
MDR Text Key | 265862288 |
Report Number | 9680001-2021-00067 |
Device Sequence Number | 1 |
Product Code |
OAE
|
UDI-Device Identifier | 07640157990033 |
UDI-Public | 07640157990033 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | P130026 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
08/10/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/10/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/25/2022 |
Device Model Number | PN-004 065 |
Device Catalogue Number | PN-004065 |
Device Lot Number | 7525964 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/22/2021 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 07/30/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/27/2020 |
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 |