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	11/18/2019
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
During an atrial fibrillation procedure, a pericardial effusion occurred while maneuvering the catheters in the left atrium.Following a successful transseptal puncture, the left atrium anatomy was collected with the flexibility sensor enabled ablation catheter.While moving the device between the right superior pulmonary vein and the left atrium roof, an abnormal vertical movement of the catheter was observed, which likely perforated the left atrium or the vein wall.The patient became hypotensive and a pericardial effusion was diagnosed with echocardiographic imaging.A pericardiocentesis was performed which successfully restored normal arterial pressure.Echocardiographic imaging also confirmed that the effusion was completely drained.The procedure was stopped and the patient was stable.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 cardiac perforation 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: 9382984
• Report Number: 3008452825-2019-00592
• Device Sequence Number: 19429406
• 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): 12/27/2019

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: 04/30/2021
• Device Model Number: A-FASE-F
• Device Lot Number: 6443338
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 12/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Weight: 90