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-F
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation ablation procedure, while in the left atrium for a pulmonary vein isolation with substrate modification, a steam pop occurred during ablation and the patient became hypotensive and a pericardial effusion was diagnosed via ultrasound.No medical intervention was deemed necessary and the patient left the procedure room in stable condition.There were no performances issues with the device.
Additional Manufacturer Narrative
One quadripolar, uni-directional, curve f, flexibility sensor enabled ablation catheter was received for evaluation.The catheter met specifications for electrical and temperature testing, and functioned per requirements during an irrigation flow test.The catheter deflected when actuating the steering mechanism and the curve dimensions met specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported pericardial effusion remains unknown.Per the ifu, vascular perforation is an inherent risk of any electrode placement.  .
Additional Manufacturer Narrative
Corrected information: h6.

• 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: 12008204
• Report Number: 3008452825-2021-00334
• Device Sequence Number: 19992703
• Product Code: OAD
• UDI-Device Identifier: 05415067020048
• UDI-Public: 05415067020048
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 01/11/2022

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: 02/29/2024
• Device Model Number: A-FASE-F
• Device Catalogue Number: A-FASE-F
• Device Lot Number: 7885458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 08/05/2021; 01/11/2022
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 08/05/2021; 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2021
• 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