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	03/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.In addition, no log files were received.  information from the field indicates ablations were performed with rf power of 50 watts.The ifu warns rf power in excess of 30w is associated with a higher likelihood of pericardial effusion occurrence.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 was due to ablating at 50 watts.
Event or Problem Description
Following a supraventricular tachycardia ablation, a pericardial effusion occurred.The ablation procedure was for a concealed left lateral bypass tract.Transseptal access was obtained and ablation was performed successfully which eliminated the lateral bypass tract.Post procedure, the patient was hypotensive.A pericardial effusion was observed on fluoroscopy and an echocardiogram was used to confirm the effusion.No intervention was needed to treat the effusion.The physician believed the pericardial effusion was due to ablating at 50 watts.There were no performance issues with any abbott 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: 8513769
• Report Number: 3005334138-2019-00206
• Device Sequence Number: 16624819
• Product Code: OAE
• UDI-Device Identifier: 05415067027702
• UDI-Public: 05415067027702
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2019

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: 05/31/2020
• Device Model Number: A-TCSE-J
• Device Lot Number: 6780320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/15/2019
• 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