MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	A-FASE-DF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Thrombosis/Thrombus (4440)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Following an index procedure that took place on (b)(6) 2024, a thrombus and pericardial effusion was found requiring diuretic medication and a pericardiocentesis.The patient returned to the hospital on (b)(6) 2024, hypotensive with recurrent episodes of ventricular tachycardia and was started on lidocaine.On (b)(6) 2024, a transthoracic echocardiogram revealed a left ventricular thrombus.Lidocaine was stopped and heparin was started.The patient was diuresed with po torsemide 40mg daily and transferred to another hospital on (b)(6) 2024.An echocardiogram obtained on (b)(6) 2024, showed notable ef 15-25% with no left ventricular apical thrombus, rvsp 40-45 with a large circumferential pericardial effusion concerning for early tamponade physiology.Given no evidence of recurrent thrombus, the heparin drip was stopped.On (b)(6) 2024, the patient underwent pericardiocentesis with 1400 milliliters of serosanguineous fluid removed and a pericardial drain was placed.A transthoracic echocardiogram had not been performed after the index procedure.There were no alleged issues with any abbott devices.
Additional Manufacturer Narrative
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 thrombus and pericardial effusion remain unknown.Per the ifu, vascular perforation is an inherent risk of any electrode placement.
Event or Problem Description
Following an index procedure that took place on (b)(6) 2024, a thrombus and pericardial effusion was found requiring diuretic medication and a pericardiocentesis.The patient returned to the hospital on (b)(6) 2024, hypotensive with recurrent episodes of ventricular tachycardia and was started on lidocaine.On (b)(6) 2024, a transthoracic echocardiogram revealed a left ventricular thrombus.Lidocaine was stopped and heparin was started.The patient was diuresed with po torsemide 40mg daily and transferred to another hospital on (b)(6) 2024.An echocardiogram obtained on (b)(6) 2024, showed notable ef 15-25% with no left ventricular apical thrombus, rvsp 40-45 with a large circumferential pericardial effusion concerning for early tamponade physiology.Given no evidence of recurrent thrombus, the heparin drip was stopped.On (b)(6) 2024, the patient underwent pericardiocentesis with 1400 milliliters of serosanguineous fluid removed and a pericardial drain was placed.A transthoracic echocardiogram had not been performed after the index procedure.There were no alleged issues with any abbott devices.The patient is stable.The physician alleges that the pericardial effusion was a reaction to epicardial access.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿
• Common Device Name: 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19515293
• Report Number: 3008452825-2024-00311
• Device Sequence Number: 11598226
• Product Code: OAD
• UDI-Device Identifier: 05415067020062
• UDI-Public: (01)05415067020062(10)8687403(17)250831
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: A-FASE-DF
• Device Catalogue Number: A-FASE-DF
• Device Lot Number: 8687403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 07/18/2024; 08/01/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/24/2024; 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male