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-FJ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During a typical flutter ablation, an effusion occurred and a pericardiocentesis was performed to stabilize the patient.It was noticed that the heart silhouette wasn¿t beating as much as it was at the start on fluoroscopy.An echocardiogram revealed an effusion, and a pericardiocentesis was done to stabilize the patient.It is unknown the cause of the perforation or where it occurred, although it was likely in the right atrium.
Additional Manufacturer Narrative
One quadripolar, bi-directional, curve f-j, flexability sensor enabled ablation catheter was received for evaluation.The catheter met specifications for electrical and temperature testing and met acceptable irrigation rates during a flow test.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported effusion remains unknown.Per the ifu, vascular perforation is an inherent risk of any electrode placement.

• 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: 15798915
• Report Number: 3008452825-2022-00685
• Device Sequence Number: 3038951
• Product Code: OAD
• UDI-Device Identifier: 05415067020086
• UDI-Public: 05415067020086
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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: 02/28/2025
• Device Model Number: A-FASE-FJ
• Device Catalogue Number: A-FASE-FJ
• Device Lot Number: 8392735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/14/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2022
• 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 Sex: Unknown