MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE J; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	A-TCSE-J
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer number: 2030404-2018-00055, 3008452825-2018-00265.At the end of the atrial fibrillation procedure, a pericardial effusion occurred.After isolating the veins the patient became hypotensive.An echocardiogram revealed a pericardial effusion for which a pericardiocentesis was performed to stabilize the patient.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; however, the log files from the tactisys quartz system were returned.The log file analysis concluded that the tacticath catheter performed as intended.The optical fibers met specifications, the recorded temperatures indicated cooling during rf ablation, and contact force measurements were displayed throughout the duration of the log files.Force measurements were recorded during ablation that exceeded the recommended values in the tacticath contact force ablation catheter, sensor enabled instructions for use (ifu); however, due to unknown procedural conditions we are unable to conclusively determine the cause of the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ UNID CURVE J
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7755374
• Report Number: 3005334138-2018-00242
• Device Sequence Number: 1319833
• Product Code: OAE
• UDI-Device Identifier: 05415067027702
• UDI-Public: 05415067027702
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/18/2018

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: 11/30/2019
• Device Model Number: A-TCSE-J
• Device Lot Number: 6513948
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 09/18/2018
• 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: INQUIRY OPTIMA DIAGNOSTIC CATHETER; INQUIRY STEERABLE DIAGNOSTIC CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR