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 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

One bi-directional, curve d-f, tactiflex ablation catheter, sensor enabled (g5) was received for evaluation. the reported signal issue and displaced electrode 3 was confirmed.Electrode 3 read as an open circuit during electrical testing, consistent with the reported signal issue.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.Electrode 3 was shifted distally causing a fracture in conductor wire 3 at the weld joint, consistent with the open circuit detected.

Event Description

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

Event Description

This report is to advise of an event observed during analysis confirming an exposed internal wire on the catheter.

Manufacturer Narrative

Corrected information: b5, h10.Additional information: g6, h2.One bi-directional, curve d-f, tactiflex ablation catheter, sensor enabled (g5) was received for evaluation.Electrode 3 read as an open circuit during electrical testing, consistent with the reported signal issue.Electrode 3 was shifted distally fracturing and exposing conductor wire 3 at the weld joint, consistent with the open circuit detected.

• 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: 11482450
• MDR Text Key: 243936676
• Report Number: 3005334138-2021-00174
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1