MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA TACTICATH CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED UNID CURVE F; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number A-TCSE-F

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

During the procedure, an effusion was noted.The case was not completed due to a cardiac effusion.During the procedure, the user delivered lesions in left atrium at high power 50 watts and a flow rate of 2 ml/min for 2 lesions prior to finding this issue.The case did employ an attempt at hpsd lesions, but the user did not program the autoflow to 30 ml/min when going on rf over 30w.The case was not completed due to a cardiac effusion.It is unknown if any intervention was required, the patient status is unknown at this time.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The event description indicated ablations were performed with rf power of 50w and an irrigation flow rate of 2 ml/min.The tacticath contact force ablation catheter, sensor enabled instructions for use (ifu) recommends a minimum irrigation flow rate of 30 ml/min for ablation events greater than 30w.The ifu also warns ¿too high rf power during ablation may lead to perforation caused by steam pop;¿ however, due to unknown procedural conditions we are unable to conclusively determine the cause of the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported perforation was due to user error.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

During a repeat atrial fibrillation ablation procedure, an effusion was noted.The case was not completed due to a cardiac effusion.During the procedure, the site delivered lesions in left atrium at high power 50 watts and a flow rate of 2 ml/min for 2 lesions prior to finding this issue.The case did employ an attempt at hpsd lesions, but the site did not program the autoflow to 30 ml/min when going on rf over 30w.This resulted in high temperatures of 60-70 degrees and one impedance rise.When this was discovered the left heart border was moving well and the patient was hemodynamically stable.The patient went into af requiring cardioversion which caused atrial tachycardia.The atrial tachycardia terminated during pulmonary vein isolation ablations.At the end of the case when waking up, the patient complained of central chest pain, was hemodynamically stable with no ecg changes.An echocardiogram revealed a circumferential pericardial effusion.No pericardial drain required and the patient was transferred to ccu for observation.

• Brand Name: TACTICATH CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED UNID CURVE F
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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: 10414162
• MDR Text Key: 203142374
• Report Number: 3008452825-2020-00394
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027696
• UDI-Public: 05415067027696
• 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,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: A-TCSE-F
• Device Catalogue Number: A-TCSE-F
• Device Lot Number: 7261900
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR