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 Code	Cardiac Perforation (2513)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a paroxysmal atrial fibrillation procedure, a pericardial effusion occurred which was confirmed with an echocardiogram and required a pericardiocentesis followed by surgery to stabilize the patient.During the procedure, all 4 pulmonary vein isolations were completed and the physician was attempting to position the catheter to the anterior right inferior pulmonary vein when a decrease in blood pressure was noted.The procedure was stopped and an echocardiogram was done to diagnose the pericardial effusion, a perforation located on the roof of the left atrium.A pericardiocentesis was performed and over 1100ml fluid was drained but it did not resolve.The patient was transferred to theater for surgery.The physician believes the perforation happened during catheter manipulation.The patient is in the intensive care unit and is stable.There are no reported performance issues with any abbott device.
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 incident could not be conclusively determined.

• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17700086
• Report Number: 3008452825-2023-00378
• Device Sequence Number: 18022850
• Product Code: OAD
• UDI-Device Identifier: 05415067020062
• UDI-Public: 05415067020062
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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: 11/30/2025
• Device Model Number: A-FASE-DF
• Device Lot Number: 8800873
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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; Life Threatening
• Patient Sex: Unknown