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-F
Medical Device Problem Codes	Communication or Transmission Problem (2896); Temperature Problem (3022)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	11/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturing ref: (b)(4).During the parox atrial fibrillation, native atrial tachycardia, and typical atrial flutter procedure, there was a pericardial effusion, requiring drainage.The following issues with ensite x occurred during the procedure: when the procedure was started the system showed that the magnet was not connected.All of the cables were in place.The cable near the field frame was not properly connected and once that was fixed the amplifier started as normal.The prs-a was moved twice to set the metal baseline in a normal detector position.In voxel mode the metal baseline was set and there was a lot of voxel when mapping was started with the hd grid.But the catheter was in low confidence which appeared to be related to irregular respiration and being inside the veins.Respiration compensation was not working as intended and the respiration rejection had to be turned off to complete ablation and mapping.Point collection on the shaft caused false space and there was a lot of interpolation between the veins.There was a lot of complex substrate.The lap map picked up a lot of wrong points related to artifact, which was caused by turning off the enhanced noise rejection and due to the ventricular far-field.Outlaver helped but there was still a lot of incorrect color on the la anterior wall related to the ventricular far-field.The ablation catheter was intermittently red and was showing poor se quality.The connection cable was swapped, but the ablation catheter started to show temperature alarm in power control/temp cut off mode.The ablation catheter was swapped and the issue was resolved.The blood pressure dropped and an echo was done to confirm pericardial effusion.A pericardiocentesis was done and the ablation was continued and the model and map were correct.The procedure was successfully completed with no patient consequences.
Additional 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.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿
• Common Device Name: 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: 15844936
• Report Number: 3008452825-2022-00696
• Device Sequence Number: 5717278
• Product Code: OAD
• UDI-Device Identifier: 05415067020048
• UDI-Public: 05415067020048
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: A-FASE-F
• Device Catalogue Number: A-FASE-F
• Device Lot Number: 8451036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENSITE¿ X SOFTWARE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown