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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event were requested but not received.
Event or Problem Description
Related manufacturer reference: 3008452825-2020-00027, 3005334138-2020-00024.During a tricuspid valve ablation procedure, a pericardial effusion occurred.Following transeptal puncture, substrate mapping of the left ventricle was started with the ablation catheter and then with mapping catheter.After a few minutes, the patient became hypotensive.Echocardiogram confirmed a pericardial effusion for which a pericardiocentesis was performed to stabilize the patient.The cause and location of the effusion remains unknown.There were no 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 respiratory failure and subsequent death could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• 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
• MDR Report Key: 9606611
• Report Number: 3008452825-2020-00028
• Device Sequence Number: 14133433
• Product Code: OAD
• UDI-Device Identifier: 05415067020048
• UDI-Public: 05415067020048
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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: 09/30/2022
• Device Model Number: A-FASE-F
• Device Catalogue Number: A-FASE-F
• Device Lot Number: 7229438
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿; BRK¿ TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Weight: 115