MAUDE Adverse Event Report: Abbott Medical TactiCath¿ Contact Force Ablation Catheter, Sensor Enabled¿ UniD Curve D; Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

Model Number	A-TCSE-D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation procedure with a tacticath se catheter and non-abbott (boston scientific sureflex) sheath, the patient experienced a drop in blood pressure from 122/74 to 73/55 mmhg.The procedure was stopped and a routine postoperative ultrasound was performed.A pericardial effusion was detected, and the condition was diagnosed as an acute tamponade.It was noted that the procedure was difficult from the start due to atypical patient anatomy of the venous course and a "strange cardiac axis".After the left atrium was mapped, it was determined an additional lspv had not yet been treated.During ablation, there were several instances of contact pressure spikes or around 160 g on the tacticath catheter.The physician attributed this to the "poor quality" of the non-abbot (boston scientific sureflex) sheath and patient anatomy.Approximately 6 minutes later the patient experienced the drop in blood pressure.The patient was discharged after 2 nights of monitoring.The physician stated there were no performance issues with any abbott devices.

• Brand Name: TactiCath¿ Contact Force Ablation Catheter, Sensor Enabled¿ UniD Curve D
• Common Device Name: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
• Manufacturer (Section D): Abbott 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): Abbott 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 ; +1(651)756-5400
• MDR Report Key: 50937931
• Report Number: 3008452825-2026-00490
• Device Sequence Number: 16142261
• Product Code: OAE
• UDI-Device Identifier: 05415067027689
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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 Model Number: A-TCSE-D
• Device Catalogue Number: A-TCSE-D
• Device Lot Number: 11231229
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2024
• 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: Hospitalization
• Patient Sex: Unknown