Brand Name | TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER |
Type of Device | CARDIAC ABLATION PERCUTANEOUS CATHETER |
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. (JUAREZ) |
calle hertz 1525-6 |
parque industrial j. bermudez |
ciudad juarez, chihuahua 32470 |
MX
32470
|
|
Manufacturer Contact |
denise
johnson
|
5050 nathan lane north |
plymouth, MN 55442
|
6517564470
|
|
MDR Report Key | 5316903 |
MDR Text Key | 34075622 |
Report Number | 9680001-2015-00046 |
Device Sequence Number | 1 |
Product Code |
OAE
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
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,Followup,Followup |
Report Date |
12/10/2015 |
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 | 07/25/2016 |
Device Model Number | PN-004 075 |
Device Lot Number | 4718335 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/10/2015
|
Initial Date FDA Received | 12/21/2015 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 12/23/2015 01/07/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/25/2014 |
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) |
Death;
Required Intervention;
|
Patient Age | 65 YR |