MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿; CARDIAC ABLATION PERCUTANEOUS CATHETER

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  malfunction  

Event Description

Manufacturing ref: (b)(4).During a premature ventricular contractions procedure, while the tactiflex se ablation catheter was in the patient and visualized by the mapping system, the catheter appeared "curved" on the display.This impeded the visibility of the force arrow and the confidence in the catheter location within the heart.The device was replaced with another tactiflex se ablation catheter, but the same issue occurred.The catheter was then switched to a non-irrigated safire catheter for the remainder of the ablation.The procedure was completed with no adverse patient consequences.

Manufacturer Narrative

An image, video, and case study were submitted showing a curved catheter.The results of the investigation are inconclusive since the device was not returned for analysis.The reported event of ¿the catheter appeared ¿curved¿ on the display¿ was confirmed.Based on the information received, the cause of the reported display issue and subsequent could not be conclusively determined.

• Brand Name: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18315664
• MDR Text Key: 330355021
• Report Number: 3005334138-2023-00566
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P220013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿