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

Model Number A-TCSE-DF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/08/2021

Event Type  Injury  

Event Description

During the beginning of a ventricular tachycardia procedure, after gaining access via retro aortic approach, there were difficulties while trying to ascend the catheter in the aorta.After several tries, the procedure was stopped as the patient was complaining of pain next to the stomach and the patient tension was lower than at the beginning of the procedure.After a few minutes, the tension improved but the procedure was stopped.The patient was stable when leaving the operating room, but was still complaining about pain and was transferred to cardiac surgery in case of potential aortic dissection.In recovery, an aortic hematoma was diagnosed.No intervention was taken and the patient was monitored for a few days.The patient remained stable and was discharged on (b)(6) 2021.The physician alleged the aortic hematoma was due to difficulties ascending the device into the aorta.The diameter of the patient's aorta was narrow as this was an elderly patient.

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 and contact force measurements were displayed throughout the duration of the log files.No ablations were performed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

• Brand Name: TACTICATH CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED BID CURVE D-F
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11286031
• MDR Text Key: 230493072
• Report Number: 3005334138-2021-00012
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: A-TCSE-DF
• Device Catalogue Number: A-TCSE-DF
• Device Lot Number: 7666099
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention