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 Optical Problem (3001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2020

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 ref: 2184149-2020-00192, 3008452825-2020-00621.During an atrial fibrillation ablation procedure, it was not possible to synchronize the contact force data with ensite precision and the procedure was cancelled.When the catheter was connected to the tactisys, the contact force did not synchronize.The tactisys was noted to be communicating with ensite precision and the catheter was also recognized by the system, but the contact force was still unavailable.When the contact force was attempted to be reset, both through the tactisys and ensite precision software button, the tactisys did not execute the function.It was then noted that the light on the tactisys intermittently turned green and red.The tactisys was rebooted several times, and the catheter was replaced, however the issue remained.The catheters were not inserted into the patient.The procedure was cancelled 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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.A review of the evaluation performed on the tactisys involved in the reported event determined the root cause of the event was tactisys related.

• 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: 10859890
• MDR Text Key: 216836581
• Report Number: 3008452825-2020-00620
• 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: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: A-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Device Lot Number: 7554664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TACTICATH ABLATION CATHETER, SENSOR ENABLED; TACTISYS QUARTZ ABLATION SYSTEM; TACTICATH ABLATION CATHETER, SENSOR ENABLED; TACTISYS QUARTZ ABLATION SYSTEM
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 72