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

Model Number A-TFSE-DF

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 01/02/2024

Event Type  Injury  

Event Description

During a ventricular tachycardia procedure, a pericardial effusion occurred requiring a pericardiocentesis.After mapping and ablating the areas of interest, the patient became hypotensive.An echography showed a pericardial effusion around the right ventricular apex.Once the pericardiocentesis was performed, the blood pressure began to increase again, and the patient was stable at the end of the procedure.It is unknown when the pericardial effusion occurred, but due to the location the physician believes the right ventricular catheter may have been the cause.

Event Description

During a ventricular tachycardia ablation, a pericardial effusion occurred requiring a pericardiocentesis.After mapping and ablating the areas of interest, the patient became hypotensive.An echography showed a pericardial effusion around the right ventricular apex.Once the pericardiocentesis was performed, the blood pressure began to increase again, and the patient was stable at the end of the procedure.It is unknown when the pericardial effusion occurred, but due to the location, the physician alleges the right ventricular catheter to have been the cause, a non-abbott catheter (microport decapolar xtrem).There were no alleged issues with any abbott devices.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.Per the ifu, cardiac perforation is a known risk during the use of this device.Due to the location of the effusion, the physician alleges the right ventricular catheter to have been the cause, a non-abbott catheter (microport decapolar xtrem).There were no alleged issues with any abbott devices.

• 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: 18470496
• MDR Text Key: 332378468
• Report Number: 3005334138-2024-00006
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A-TFSE-DF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2024
• 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): Required Intervention