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

Model Number A-TCSE-DF

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

Patient Problem No Information (3190)

Event Date 07/09/2018

Event Type  Injury  

Event Description

Following an atrial fibrillation ablation procedure the patient experienced complications and was transferred to another hospital.No further information is available.

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, sensor enabled 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 device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported patient complication remains unknown.

Event Description

Related manufacturer reference: 3005334138-2018-00290.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7756249
• MDR Text Key: 116209280
• Report Number: 3005334138-2018-00248
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: 05415067027641
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: A-TCSE-DF
• Device Lot Number: 6296706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization