MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number A-TCSE-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 08/24/2023

Event Type  Injury  

Event Description

During a premature ventricular contraction procedure, the patient had a pericardial effusion that required a pericardiocentesis.The physician does not allege that there was any issue with any abbott devices.

Event Description

Further information received confirmed there was an initial miscommunication that an adverse event occurred during a premature ventricular contraction procedure.Further clarification confirmed that there were no abbott devices involved in the procedure.

Manufacturer Narrative

Corrected information: further information received confirmed an initial miscommunication that an adverse event occurred during a premature ventricular contraction procedure.Further clarification confirmed that there were no abbott devices involved in the procedure.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 event could not be conclusively determined.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 17761650
• MDR Text Key: 323576497
• Report Number: 3008452825-2023-00403
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 05415067027641
• UDI-Public: 05415067027641
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130026
• 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: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A-TCSE-DF
• Device Lot Number: 9115629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2023
• 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