MAUDE Adverse Event Report: Abbott Medical FlexAbility¿ Ablation Catheter, Bi-D, Curve D-F; Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Model Number	A701125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury

• Brand Name: FlexAbility¿ Ablation Catheter, Bi-D, Curve D-F
• 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 ; +1(651)756-5400
• MDR Report Key: 50902644
• Report Number: 3008452825-2026-00523
• Device Sequence Number: 21523079
• Product Code: OAD
• UDI-Device Identifier: 05415067011114
• UDI-Public: (01)05415067011114(10)11316908(17)290228
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110016
• 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): 09/25/2026

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: A701125
• Device Catalogue Number: A701125
• Device Lot Number: 11316908
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2026
• 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: Male