MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿; CARDIAC ABLATION PERCUTANEOUS CATHETER

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Cardiac Perforation (2513); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2023

Event Type  Injury  

Event Description

During a redo case after previous ablation for avrt, the tachycardia was terminated, and the procedure was successfully completed without any patient issues.Two hours after the procedure the patient had a pericardial effusion after epicardial ablation and access, so pericardial suction was performed.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.In addition, no log files were received.An event of a possible pericardial effusion was reported.However, an echocardiogram confirmed there was no effusion making this a non reportable event.

Event Description

During a redo case after previous ablation for avrt, the tachycardia was terminated, and the procedure was successfully completed without any patient issues.Two hours after the procedure it was suspected that the patient had a pericardial effusion.However, an echocardiogram confirmed there was no effusion.No adverse effects to the patient occurred.

Manufacturer Narrative

Further information was received that an echocardiogram confirmed there was no effusion.The procedure was successfully completed and there were no adverse effects to the patient, making this event not reportable.

• Brand Name: TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17319996
• MDR Text Key: 319009503
• Report Number: 3005334138-2023-00311
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P220013
• 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,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Required Intervention