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

Model Number A-FASE-FJ

Device Problem Signal Artifact/Noise (1036)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

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 incident could not be conclusively determined.

Event Description

Related manufacturer report number: 3005334138-2020-00654.During a vt ablation procedure, noise was noted on the catheter.A second device was attempted, but the same issue occurred.A third device was attempted, and the noise was still present.However, the procedure was continued with the third catheter with the noise present and no adverse consequences to the patient.A clinically significant delay occurred and the patient was given additional anesthesia during the procedure due to this issue.

Manufacturer Narrative

Additional information: d9, g3, g6, h2, h3, h6.One bi-directional, curve f-j, tacticath sensor enabled contact force ablation catheter was received for evaluation.Electrical testing of the returned device determined electrodes 1-4 met specifications for acceptable resistance values with no open or short circuits detected.A simulated ablation test was conducted; however, noise was not present on the distal electrode before, during, or after ablation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported noise issue remains unknown.

• Brand Name: FLEXABILITY ABLATION CATHETER, SENSOR ENABLED
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL; 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: 11089721
• MDR Text Key: 224149716
• Report Number: 3008452825-2020-00732
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067020086
• UDI-Public: 05415067020086
• Combination Product (y/n): N
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: A-FASE-FJ
• Device Catalogue Number: A-FASE-FJ
• Device Lot Number: 7545698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TACTICATH SE; TACTICATH SE
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 104