MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED BID CURVE D-F; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number A-TCSE-DF

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer report numbers: 2184149-2020-00181, 2184149-2020-00180.During procedure, the communication between ensite and ampere and tactisys was unstable, and when the catheter was connected, communication with ampere and tactisys was disconnected.When the tactisys was rebooted, communication was sometimes possible and sometimes not, and when the tacticath was connected, communication was stopped again.Since the same phenomenon occurred multiple times, the tactisys was repeatedly rebooted and eventually was able to communicate.However, because the study was stopped for more than 30 minutes, propofol was additionally administered to the patient.The contact force value was about 10 g before the rf delivery, but it increased rapidly to about 30 g immediately after the rf delivery.The procedure was completed without replacing the devices and there were no adverse consequences to the patient.

Manufacturer Narrative

One bi-directional, curve d-f, tacticath sensor enabled contact force ablation catheter was received for evaluation.Contact force was displayed when connected to the tactisys unit, with no error messages noted.The device met specifications for optical signal properties and the deformable body thermocouple met specifications during electrical testing.A simulated ablation test was conducted with no contact force issues or other anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

• Brand Name: TACTICATH CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED BID CURVE D-F
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 10744694
• MDR Text Key: 213407000
• Report Number: 3008452825-2020-00588
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: 05415067027641
• Combination Product (y/n): N
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

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: 05/31/2021
• Device Model Number: A-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Device Lot Number: 7311661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 12/12/2020
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMPERE.; TACTISYS QUARTZ.; AMPERE; TACTISYS QUARTZ
• Patient Outcome(s): Other