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. |
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 | 6048676 |
MDR Text Key | 58179825 |
Report Number | 9680001-2016-00081 |
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 |
Report Date |
09/29/2016 |
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 | 05/25/2017 |
Device Model Number | PN-004 065 |
Device Lot Number | 5115859 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/29/2016
|
Initial Date FDA Received | 10/21/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 12/07/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/14/2015 |
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 | AGILIS NXT INTRODUCER; AMPERE GENERATOR; ENSITE VELOCITY SYSTEM; REFLEXION SPIRAL CATHETER |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 46 YR |