TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F
Report
- Report Number
- 3008452825-2025-00147
- Event Type
- Death
- Date Received
- April 1, 2025
- Date of Event
- March 26, 2025
- Report Date
- October 1, 2025
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- OAE
- UDI-DI
- 05415067027641
- PMA / PMN Number
- P130026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: B5, D9, G3, H2, H3, H6. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
ADDITIONAL INFORMATION: B5, D9, G3, H2, H3, H6. ONE BI-DIRECTIONAL, CURVE D-F, TACTICATH SENSOR ENABLED CONTACT FORCE ABLATION CATHETER WAS RECEIVED FOR EVALUATION. WHEN THE RETURNED DEVICE WAS CONNECTED TO THE TACTISYS QUARTZ UNIT, OPTICAL FIBERS 1-3 MET SPECIFICATIONS FOR OPTICAL PROPERTIES AND CONTACT FORCE WAS DISPLAYED WITH NO ERROR MESSAGES NOTED. ELECTRODES 1-4 AND BOTH THERMOCOUPLES MET SPECIFICATIONS DURING ELECTRICAL TESTING. HOWEVER, ONE OF THE MAGNETIC SENSORS READ AS AN OPEN CIRCUIT DURING ELECTRICAL TESTING DUE TO A FRACTURE IN SENSOR WIRE 2 WITHIN THE 10-PIN CONNECTOR, CONSISTENT WITH THE REPORTED EVENT. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE FRACTURED WIRE REMAINS UNKNOWN.
DURING THE VENTRICULAR TACHYCARDIA PROCEDURE, IT WAS FOUND THAT THE CATHETER WAS NOT RECOGNIZED BY THE SYSTEM. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. IT WAS LATER REPORTED THAT FOLLOWING THIS INITIAL PROCEDURE ON (B)(6) 2025, THE PATIENT RETURNED TO THE ICU BECAUSE HE WAS IN SERIOUS HEALTH CONDITION. ON (B)(6) 2025, THE PATIENT WAS NOT IMPROVING SO UNDERWENT ANOTHER PROCEDURE THAT MORNING AND RETURNING TO THE ICU TO RECOVER. LATER THAT SAME DAY, THE PATIENT WAS STILL NOT IMPROVING SO UNDERWENT ANOTHER PROCEDURE THAT AFTERNOON, BUT UNFORTUNATELY THERE WAS STILL NO IMPROVEMENT IN THE PATIENT'S CONDITION AND HE RETURNED TO THE ICU. THE PATIENT DIED ON (B)(6) 2025. THE PATIENT WAS ALREADY IN A SERIOUS HEALTH CONDITION AND DID NOT SHOW IMPROVEMENT FROM THE SURGICAL INTERVENTIONS. THE CAUSE OF DEATH IS NOT RELATED TO ANY ABBOTT DEVICE.
DURING THE VENTRICULAR TACHYCARDIA PROCEDURE, IT WAS FOUND THAT THE CATHETER WAS NOT RECOGNIZED BY THE SYSTEM. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. IT WAS LATER REPORTED THAT FOLLOWING THIS INITIAL PROCEDURE ON "(B)(6) 2026," THE PATIENT RETURNED TO THE ICU BECAUSE HE WAS IN SERIOUS HEALTH CONDITION. ON (B)(6) 2025, THE PATIENT WAS NOT IMPROVING SO UNDERWENT ANOTHER PROCEDURE THAT MORNING AND RETURNING TO THE ICU TO RECOVER. LATER THAT SAME DAY, THE PATIENT WAS STILL NOT IMPROVING SO UNDERWENT ANOTHER PROCEDURE THAT AFTERNOON, BUT UNFORTUNATELY THERE WAS STILL NO IMPROVEMENT IN THE PATIENT'S CONDITION AND HE RETURNED TO THE ICU. THE PATIENT DIED ON (B)(6) 2025. THE PATIENT WAS ALREADY IN A SERIOUS HEALTH CONDITION AND DID NOT SHOW IMPROVEMENT FROM THE SURGICAL INTERVENTIONS.
THE DEVICE WAS RECEIVED. THIS FOLLOW-UP REPORT INCLUDES THE UPDATED ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 650078 | TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION | OAE | ST. JUDE MEDICAL | A-TCSE-DF | 10248587 | 05415067027641 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |