MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE F-J; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number A-TCSE-FJ

Device Problems Positioning Failure (1158); Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

During an ablation procedure a clinically significant delay occurred.While the tacticath se catheter was inside the patient the visual representation on ensite precision appeared distorted and could not be corrected.Additionally the distal tip of the catheter remained deflected and could not be used to apply radiofrequency energy to the target location.A new catheter was used to resolve the issue and complete the procedure.

Manufacturer Narrative

One tacticath sensor enabled contact force ablation catheter was received for evaluation.The catheter shaft deflected in both directions when the steering mechanism was actuated and met specifications for curve shape.Electrical testing of the returned device determined electrodes 1-4 met specifications, however the magnetic sensor displayed multiple short circuits consistent with the reported issue.Further inspection revealed corrosion in the 10-pin redel connector, consistent with the observed short circuits.The device met specifications during leak testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The root cause of the corrosion within the 10-pin redel connector and subsequent prolonged procedure could not be conclusively determined.

Event Description

On 12february2020 additional information was received confirming the procedure was not clinically significant delayed, as initially reported.This report was only to advise of an event observed during analysis confirming a short circuit of the catheter.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE F-J
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 8797742
• MDR Text Key: 151275857
• Report Number: 3008452825-2019-00343
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027665
• UDI-Public: 05415067027665
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: A-TCSE-FJ
• Device Catalogue Number: A-TCSE-FJ
• Device Lot Number: 6839009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR