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 Material Deformation (2976)

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

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

One bi-directional, curve d-f, tactiflex ablation catheter, sensor enabled was received for evaluation.Microscopic investigation revealed electrode ring 3 was shifted distally on the catheter shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the investigation preformed and the information provided, the root cause of the detected issue could not be confirmed.

Event Description

This report is to advise of an event observed during analysis confirming a displaced electrode.

Manufacturer Narrative

One bi-directional, curve d-f, tactiflex ablation catheter, sensor enabled (g5) was received for evaluation.Electrode ring 3 was dissected and conductor wire 3 was confirmed to be fractured just proximal to its weld joint to the electrode ring.The weld itself on electrode ring 3 was confirmed to be intact and not the cause of the open circuit.The conductor wire 3 fracture was confirmed to be the cause of the intermittent open circuit on electrode 3.The cause of the conductor wire 3 fracture is consistent with the shifted electrode ring 3.The root cause of the reported event is consistent with the intermittent open circuit detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the investigation preformed and the information provided, the root cause of the detected issue could not be confirmed.

• 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: 12366461
• MDR Text Key: 268096519
• Report Number: 3005334138-2021-00544
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: A-TFSE-DF-CLIN
• Device Lot Number: 7916485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1