FDA Adverse Event
Malfunction
Summary report: N
TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE F-J
MDR report key: 14841717
·
Received June 28, 2022
Report
- Report Number
- 3008452825-2022-00505
- Event Type
- Malfunction
- Date Received
- June 28, 2022
- Date of Event
- May 31, 2022
- Report Date
- July 14, 2022
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- OAE
- UDI-DI
- 05415067027665
- PMA / PMN Number
- P130026
- Removal / Correction Number
- SEE H10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
FSCA NUMBER: 3005334138-06/09/2022-003-R.
Additional Manufacturer Narrative · 0
FSCA NUMBER: 3005334138-06/09/2022-003-R. THE REPORTED EVENT OF AN EXPIRED CATHETER ERROR MESSAGE WAS CONFIRMED. THE DEVICE WAS PROGRAMMED INCORRECTLY DURING MANUFACTURING, CONSISTENT WITH THE CATHETER BEING RECOGNIZED AS AN EXPIRED/INVALID PRODUCT AND WITH THE REPORTED EVENT.
Description of Event or Problem · 0
DURING AN ATRIAL FLUTTER ATRIAL FIBRILLATION PROCEDURE, AN ERROR MESSAGE STATING THAT THE CATHETER WAS EXPIRED APPEARED WHEN THE CATHETER WAS PLUGGED INTO THE TACTICS QUARTZ AND THE PRECISION LINK. THE ERROR MESSAGE WAS CLOSED, AND THE SE CABLE OF THE CATHETER WAS PLUGGED IN A DIFFERENT PORT OF THE PRECISION LINK, AND THE MESSAGE DID NOT REAPPEAR. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2044259 | TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE F-J | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION | OAE | ST. JUDE MEDICAL | A-TCSE-FJ | 8409675 | 05415067027665 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |