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-D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	11/07/2022
Type of Reportable Event	Death
Event or Problem Description
Following an ablation procedure, an echocardiogram revealed a pericardial effusion and the patient later expired.Ablation occurred on (b)(6) 2022 with no complications noted.On (b)(6) 2022, an effusion was noted which remained stable through periodic assessments with no action required.On (b)(6) 2022 the patient experienced a cardiac arrest with electro-mechanical dissociation.Resuscitation maneuvers were attempted for 50 minutes unsuccessfully, and the patient expired.There were no performance issues with any abbott devices.Per the physician, the patient expired due to non-cardiovascular reasons.Not due to the procedure, effusion or any other cardiovascular reasons.
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 pericardial effusion remains unknown.Per the ifu, vascular perforation is an inherent risk of any electrode placement.Per the physician, the patient expired due to non-cardiovascular reasons.Not due to the procedure, effusion or any other cardiovascular reasons.
Event or Problem Description
Following an ablation procedure, an echocardiogram revealed a pericardial effusion and the patient later expired.Ablation occurred on (b)(6) 2022 with no complications noted.On (b)(6) 2022, an effusion with no perforation was noted which remained stable through periodic assessments with no action required.On (b)(6)2022 the patient experienced a cardiac arrest with electro-mechanical dissociation.Resuscitation maneuvers were attempted for 50 minutes unsuccessfully, and the patient expired.There were no performance issues with any abbott devices.Per the physician, the patient expired due to non-cardiovascular reasons.Not due to the procedure, effusion or any other cardiovascular reasons.

• 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: 15804117
• Report Number: 3008452825-2022-00683
• Device Sequence Number: 5401471
• Product Code: OAD
• UDI-Device Identifier: 05415067020031
• UDI-Public: 05415067020031
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 01/06/2023

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: 04/30/2025
• Device Model Number: A-FASE-D
• Device Catalogue Number: A-FASE-D
• Device Lot Number: 8495865
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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: Other; Death
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 82 KG