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

Model Number A-FASE-DF

Device Problem Communication or Transmission Problem (2896)

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

Event Date 04/21/2023

Event Type  malfunction  

Event Description

During the premature ventricular contraction procedure, communication issues with the catheter and the ensite precision caused procedural delays.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.When the catheter was inserted into the heart and connected to an extension cable, the se sensor was not recognized by ensite precision.The cables were changed, the input ports were changed, the ensite precision module and ensite were restarted, but the issue persisted.The catheter was replaced, and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

The catheter successfully attached to a test box with no anomalies noted.The catheter met specifications for electrical testing.No open or short circuits were detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported recognition issue remains unknown.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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
• Manufacturer (Section G): 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
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16807002
• MDR Text Key: 313921497
• Report Number: 3008452825-2023-00176
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 05415067020062
• UDI-Public: 05415067020062
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A-FASE-DF
• Device Catalogue Number: A-FASE-DF
• Device Lot Number: 8769513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2022
• 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