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

Model Number	A-TCSE-DD
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During the premature ventricular contractions ablation procedure, a pericardial effusion occurred requiring a pericardiocentesis to stabilize the patient.After connecting the tail line of the ablation catheter, it was found that the three-dimensional system could not display the pressure value.The temperature and impedance values were displayed normally.The pressure module was restarted but the three-dimensional system still could not display the pressure value.Since there were no spare ablation catheters and pressure modules at the time, the physician chose to continue the operation.The ablation catheter was successfully positioned in the right ventricular outflow tract near the septal side after femoral vein puncture.The relatively early potential was mapped and the radiofrequency instrument showed that the temperature and impedance at the tip of the ablation catheter were normal values.After attempting ablation discharge for 60 seconds, the patient's blood pressure value was noted to drop rapidly and the basal heart rate dropped to 40 beats/minute.Since the patient was under local anesthesia, the patient's consciousness gradually became blurred.Under x-ray fluoroscopy, the patient's heart activity was extremely weak and a pericardial effusion was diagnosed with a perforation noted in the right ventricular outflow tract close to the septum.The physician immediately chose atrial continuous pacing and performed a pericardiocentesis which drained approximately 400 ml.The patient's vital signs gradually returned to normal and the operation was ended.The patient's vital signs were normal after returning to the ward and there was no significant impact on the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One bi-directional, curve d-d, tacticath sensor enabled contact force ablation catheter was received for evaluation.Optical fiber 1 no longer met specifications for optical properties when the returned device was connected to the tactisys quartz unit.Further investigation revealed optical fiber 1 intermittently met specifications for optical properties when force was applied to the distal tip, consistent with a deformation of the tip assembly and the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the deformation of the tip assembly remains unknown.

• Brand Name: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-D
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19774600
• Report Number: 3008452825-2024-00406
• Device Sequence Number: 18210079
• Product Code: OAE
• UDI-Device Identifier: 05415067027634
• UDI-Public: (01)05415067027634(10)10122209(17)250531
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P130026
• 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): 08/21/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: A-TCSE-DD
• Device Catalogue Number: A-TCSE-DD
• Device Lot Number: 10122209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown