MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH¿ SENSOR ENABLED¿ CONTACT FORCE ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	A-TCSE-JJ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	02/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation/left atrial flutter ablation procedure, a cardiac perforation occurred.Mid case, the ablation catheter was noted out of the geometry surface.The patient status began to decrease, and ice images showed an effusion.The patient was cardioverted to sinus rhythm and the effusion was monitored via ice and transesophageal echocardiogram for approximately 30 minutes.The patient was considered to be stable and transferred to unit.The patient returned to cath lab later for a pericardiocentesis and is in stable condition.There were no performance issues with any abbott devices.
Additional Manufacturer Narrative
Additional information: g3, h2, h3.An event of a pericardial effusion was reported.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.The log files indicate that contact force was reset one time outside the patient at the beginning of the log files, according to the measured temperature at the time of the reset.A ¿check baseline¿ error was displayed throughout the log files.The ensite contact force module instructions for use (ifu) states ¿baseline operation should be checked regularly and if necessary reset to zero, especially under the following circumstances: after the first insertion of the catheter into the body; after reinsertion into the patient¿s body after retraction through a sheath; when the message ¿please check baseline¿ displays.¿ in addition, force measurements were recorded during ablation that exceeded the recommended values in the tacticath se contact force ablation catheter instructions for use (ifu); however, due to the ¿check baseline¿ error, the accuracy of the measured forces during ablation cannot be determined.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.The cause of the reported cardiac perforation remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: TACTICATH¿ SENSOR ENABLED¿ CONTACT FORCE ABLATION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 13654577
• Report Number: 3008452825-2022-00075
• Device Sequence Number: 2481674
• Product Code: OAE
• UDI-Device Identifier: 05415067027672
• UDI-Public: 05415067027672
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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: 08/31/2022
• Device Model Number: A-TCSE-JJ
• Device Catalogue Number: A-TCSE-JJ
• Device Lot Number: 7872435
• 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: 02/25/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• 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 Age: 64 YR
• Patient Sex: Male