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 Codes	Stroke/CVA (1770); Fistula (1862)
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 scientific reports in an article titled, "early ablation leads to better outcome in patients < 55 years with persistent atrial fibrillation" erhard, nico, vol.14, no.1, 25 oct.2024, https://doi.Org/10.1038/s41598-024-76098-2.This retrospective single center study included a cohort of 101 patients = 55 years (at time of ablation) who were diagnosed with persistent af and underwent first-time radiofrequency catheter ablation (rfca) at our center between january 2017 and december 2020.Persistent af was defined according to current guidelines4.Patients with previous left atrial catheter ablations, other atrial arrythmias, with congenital heart defect (excluding pfo and minor asd) were excluded from the study.Patients were divided in those who underwent ablation within 12 months after af diagnosis or > 12 months after af diagnosis.Primary outcome was ablation success, defined as the absence of af recurrence.Procedure-related complications occurring within 30 days of ablation were also assessed.Ethical approval was granted from the institutional review board (ethical committee of the technical university of munich, (approval #2020 - 348_1-s-np).Due to the retrospective nature of the study, (ethical committee of the technical university of munich) waived the need of obtaining informed consent.All methods were performed in accordance with the relevant guidelines and regulations as well as in accordance with the declaration of helsinki.There was 1 occurrence of ischemic stroke 4 days post-procedure confirmed with an mri, and there was 1 occurrence of av fistula.
Event or Problem Description
The following was published in the journal scientific reports in an article titled, "early ablation leads to better outcome in patients < 55 years with persistent atrial fibrillation" erhard, nico, vol.14, no.1, 25 oct.2024, https://doi.Org/10.1038/s41598-024-76098-2.This retrospective single center study included a cohort of 101 patients = 55 years (at time of ablation) who were diagnosed with persistent af and underwent first-time radiofrequency catheter ablation (rfca) at our center between january 2017 and december 2020.Persistent af was defined according to current guidelines4.Patients with previous left atrial catheter ablations, other atrial arrythmias, with congenital heart defect (excluding pfo and minor asd) were excluded from the study.Patients were divided in those who underwent ablation within 12 months after af diagnosis or > 12 months after af diagnosis.Primary outcome was ablation success, defined as the absence of af recurrence.Procedure-related complications occurring within 30 days of ablation were also assessed.Ethical approval was granted from the institutional review board (ethical committee of the technical university of munich, (approval #2020 - 348_1-s-np).Due to the retrospective nature of the study, (ethical committee of the technical university of munich) waived the need of obtaining informed consent.All methods were performed in accordance with the relevant guidelines and regulations as well as in accordance with the declaration of helsinki.There was 1 occurrence of ischemic stroke 4 days post-procedure confirmed with an mri, and there was 1 occurrence of av fistula.The physician does not allege that the flexability catheter caused or contributed to the ischemic stroke post-procedure or fistula.
Additional Manufacturer Narrative
Additional information: b5, g3, h2, h3, h6, h11.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 fistula and stroke could not be conclusively determined.

• 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: 23086493
• Report Number: 3008452825-2025-00461
• Device Sequence Number: 21293859
• Product Code: OAD
• UDI-Device Identifier: 05415067020093
• UDI-Public: 05415067020093
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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: 10/22/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/22/2025
• 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
• Patient Sex: Unknown