MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model/lot number information was not able to be obtained for this device.Therefore, full udi information (d4) and 510k (g3) are not available.
Event or Problem Description
The following was published in the journal of clinical medicine in an article titled, "efficacy of catheter ablation using the electro anatomical system without the use of fluoroscopy in patients with ventricular extra systolic beats" rodkiewicz, dariusz, 24 july 2023, 12, 4851.Https://doi.Org/10.3390/jcm12144851.The study included 109 patients with symptomatic vebs, who were qualified for the ablation procedure based on 24 h ecg holter (more than 10.000 vebs per day).The purpose of the study was to perform every procedure following the alara rule of using fluoroscopy (as low as reasonably achievable).Only when there was a necessity arising from the factors described below, fluoroscopy was used.Completely fluoroless ca of vebs guided by the eam system was performed in 94 (86%) consecutive patients with vebs, whereas conventional fluoroscopy-guided ca was performed in 15 (13,8%) such patients.Procedures were performed between january 2020 and september 2022.Participants signed written informed consent forms.Demographic and clinical data were obtained from the medical records.There was 1 occurrence of tamponade after rf requiring a pericardiocentesis.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.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, SENSOR ENABLED¿ CATHETER
• 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23006599
• Report Number: 3008452825-2025-00440
• Device Sequence Number: 10502846
• Product Code: OAD
• UDI-Device Identifier: 05415067020093
• UDI-Public: 05415067020093
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 12/05/2025

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?: No
• Operator of Device: Health Professional
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown