MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXABILITY¿ABLATION CATHETER, UNI-D, CURVE D; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Model Number	A701157
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a premature ventricular contraction (pvc) procedure, a steam pop occurred followed by a cardiac tamponade which required a pericardiocentesis.During the fourth ablation application, a pop was heard.A decrease in blood pressure was observed and fluoroscopy revealed a cardiac tamponade.A pericardiocentesis was performed to stabilize the patient.The pvc focus was at the anterior portion of the right ventricular outflow tract, according to the physician, this anatomical location has a slightly thinner wall compared to other regions of the right ventricle.
Additional 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 incident could not be conclusively determined.Per the ifu, cardiac tamponade and pericardial effusion are known risks during the use of this device.

• Brand Name: FLEXABILITY¿ABLATION CATHETER, UNI-D, CURVE D
• Common Device Name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23646843
• Report Number: 3008452825-2025-00622
• Device Sequence Number: 4823736
• Product Code: OAD
• UDI-Device Identifier: 05415067011497
• UDI-Public: (01)05415067011497(10)9140725(17)260630
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P110016
• 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
• Report Date (Section B): 11/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: A701157
• Device Catalogue Number: A701157
• Device Lot Number: 9140725
• 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: 11/03/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2023
• 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: Life Threatening; Required Intervention
• Patient Sex: Female