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 Problems Low Blood Pressure/ Hypotension (1914); Transient Ischemic Attack (2109)

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in a subsequent submission.

Event Description

During an atrial fibrillation ablation procedure the patient experienced hypotension and a transient ischemic attack (tia).While ablating, the patient's atrial fibrillation converted, the underlying rhythm was sinus arrest with junctional escape and the patient developed associated hypotension.Intracardiac pacing was done to stabilize the patient during the procedure; however, the patient was hypotensive post procedure and required chronotropic and inotropic support in the icu.The patient's blood pressure was continually monitored following the procedure until a stable blood pressure was reached.Additionally, 50 minutes following ablation the patient was presenting with left-sided facial droop.A ct brain scan confirmed right middle cerebral artery (mca) stroke, with filling defect of the terminal right mca branches in the distal m3 region.During the procedure the active clotting time (act) was approximately 350 seconds and was maintained with heparin to reach the target act, transesophageal echo was performed prior to the start of the procedure to confirm no left atrial appendage thrombus was present.Clot retrieval was not an option and the following morning all neurological abnormalities resolved.The hypotension and tia resolved without sequela.

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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported hypotension and transient ischemic attack remains unknown.

Event Description

On (b)(6) 2019 the patient experienced a second transient ischemic attack.The patient presented with tongue deviation and tingling.A new mri was performed and confirmed embolic abnormalities.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

• 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
• MDR Report Key: 8605063
• MDR Text Key: 144869373
• Report Number: 3005334138-2019-00258
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: 05415067027641
• 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,Followup
• Report Date: 06/18/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: A-TCSE-DF
• Device Lot Number: 6303297
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/13/2019
• Supplement Dates Manufacturer Received: 05/16/2019; 06/07/2019
• Supplement Dates FDA Received: 05/31/2019; 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 102