TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 65MM
Report
- Report Number
- 9680001-2022-00041
- Event Type
- Malfunction
- Date Received
- September 2, 2022
- Date of Event
- April 12, 2022
- Report Date
- November 9, 2022
- Manufacturer
- VENUSA DE MEXICO S.A. DE C.V.
- Product Code
- OAE
- UDI-DI
- 07640157990033
- PMA / PMN Number
- P130026
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ONE 65 MM TACTICATH QUARTZ CONTACT FORCE ABLATION CATHETER WAS RECEIVED FOR EVALUATION. ELECTRODES 1-4 MET SPECIFICATIONS DURING ELECTRICAL TESTING WITH NO OPEN OR SHORT CIRCUITS DETECTED. IN ADDITION, THE CATHETER MET SPECIFICATIONS DURING LEAK TESTING. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. ADDITIONAL INFORMATION CONFIRMED THE EVENT DATE WAS APRIL 12, 2019. THE EXPIRATION DATE OF THE DEVICE WAS MAY 25, 2020.THEREFORE THE DEVICE WAS NOT EXPIRED WHEN USED
DURING THE AF PROCEDURE, NOISE WAS NOTED. THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. IN REVIEW OF THE FILE, IT WAS DETERMINED THE DEVICE USED PAST THE EXPIRATION DATE.
ADDITIONAL INFORMATION CONFIRMED THE EVENT DATE WAS APRIL 12, 2019. THE EXPIRATION DATE OF THE DEVICE WAS MAY 25, 2020. THEREFORE THE DEVICE WAS NOT EXPIRED WHEN USED AND IS NOT A REPORTABLE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314844 | TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 65MM | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION | OAE | VENUSA DE MEXICO S.A. DE C.V. | PN-004 065 | 6321187 | 07640157990033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |