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

Model Number A-TFSE-DF-CLIN

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

Patient Problem Transient Ischemic Attack (2109)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.  this event is being reported from the tactiflex ide study.

Event Description

Related manufacturing ref: 3005334138-2020-00311.One day following the ablation procedure, a possible transient ischemic attack occurred (tia).The patient presented to the hospital with a headache and vision changes.Additionally, a sudden loss of vision in the right lower quadrant of the right eye occurred on (b)(6) 2020 which resolved after one hour.Ct scan identified no hemorrhaging in the brain or evidence of infarction.The patient has no history of cerebrovascular injuries and echo was conducted prior to the procedure to rule out thrombus.The patient's act levels ranged from 230 to 389.The patient was discharged.

Manufacturer Narrative

An event of a transient ischemic attack (tia) was reported.The results of the investigation are inconclusive since the device was not returned for analysis.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 tia could not be conclusively determined.

• Brand Name: TACTIFLEX ABLATION CATHETER, SENSOR ENABLED
• 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: 10777631
• MDR Text Key: 214326921
• Report Number: 3005334138-2020-00542
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• 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: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: A-TFSE-DF-CLIN
• Device Lot Number: 7476289
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVISOR HD GRID; ADVISOR HD GRID
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 102