MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-F; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number A701125

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Perforation (2513); Thrombosis/Thrombus (4440)

Event Date 02/08/2024

Event Type  Injury  

Event Description

During a left ventricle atrial fibrillation procedure, a pericardial effusion occurred which required cardiac surgery to repair and stabilize the patient.Three femoral venous accesses and one arterial access were performed.The resident physician introduced the retroaortic flexability ablation catheter and accessed the left ventricle.When the chief physician arrived, he removed the flexability ablation catheter and inserted the 8mm tip ablation catheter.Transseptal punctures were performed and access to the left atrium were done with a swartz sheath and an agilis sheath.Using tee and the ensite mapping system, he constructed the anatomy of the left ventricle and performed some radiofrequency applications at some points using 70w or 60w of power.The anatomy of the left atrium was constructed with the circular catheter.After septal ablation of the left ventricle, the patient was cardioverted to take her out of the atrial fibrillation rhythm.The physician then placed the flexability catheter in the agilis sheath and accessed the left atrium to begin the ablation and isolation of the pulmonary veins.When the flexability catheter appeared on the ensite screen, the ablation catheter was outside the constructed geometry (the shadow was made on the decapolar catheter in the coronary sinus and on the circular catheter that was in the right superior pulmonary vein) and the other catheters were in the same position as the shadow made previously.He moved the catheter and it remained far outside the constructed geometry.An echocardiogram was performed which confirmed a pericardial effusion.A pericardiocentesis as performed and approximately 500ml was drained.The patient did not stabilize and began to form a clot so cardiac surgery was done which identified two points of possible tamponade, in the right ventricle and in the roof of the left atrium.The patient was stabilized, intubated, and transferred to the icu.The physician was unable to say when the perforation could have happened.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.However, the event states that rf applications were applied using 70w or 60w of power.The instructions for use cautions: "there is a possibility of higher incidences of steam pops at power levels exceeding 40 watts and increased collateral damage when maximum power settings (50 watts) are used.Power should be increased to these levels only if lower energies do not achieve the intended result." 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.Per the ifu, cardiac tamponade and pericardial effusion are known risks during the use of this device.

Event Description

This report includes an updated event description.During a left ventricle atrial fibrillation procedure, a pericardial effusion occurred which required cardiac surgery to repair and stabilize the patient.The patient entered the room, was monitored, anesthetized and a transesophageal echocardiogram (tee) probe was passed.Three femoral venous accesses and one arterial access were performed.The resident physician introduced the retroaortic flexability ablation catheter and accessed the left ventricle.When the chief physician arrived, he removed the flexability ablation catheter and inserted the 8mm tip ablation catheter.Transseptal punctures were performed and access to the left atrium were done with a swartz sheath and an agilis sheath.Using tee and the ensite mapping system, he constructed the anatomy of the left ventricle and performed some radiofrequency applications at some points using 70w or 60w of power.The anatomy of the left atrium was constructed with the circular catheter.After septal ablation of the left ventricle, the patient was cardioverted to take her out of the atrial fibrillation rhythm.The physician then placed the flexability catheter in the agilis sheath and accessed the left atrium to begin the ablation and isolation of the pulmonary veins.When the flexability catheter appeared on the ensite screen, the ablation catheter was observed to be outside the constructed geometry (the shadow was made on the decapolar catheter in the coronary sinus and on the circular catheter that was in the right superior pulmonary vein) and the other catheters were in the same position as the shadow made previously.The physician was asked where the catheter was and he stated it was in the left atrial appendage.He moved the catheter and it remained far outside the constructed geometry.An echocardiogram was performed which confirmed a pericardial effusion.A pericardiocentesis as performed and approximately 500ml was drained.The patient did not stabilize and began to form a clot so cardiac surgery was done which identified two points of possible tamponade, in the right ventricle and in the roof of the left atrium.The patient was stabilized, intubated, and transferred to the icu.The physician was unable to say when the perforation could have happened.There were no performance issues with any abbott device.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-F
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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
• Manufacturer (Section G): 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
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18698903
• MDR Text Key: 335295043
• Report Number: 3008452825-2024-00088
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A701125
• Device Lot Number: 9043852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening