MAUDE Adverse Event Report: ABBOTT MEDICAL, COSTA RICA LTDA FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-F; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	A701125
Medical Device Problem Codes	Fracture (1260); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an accessory pathway procedure, the catheter fractured which required replacement.After accessing the left ventricle to map the mitral annulus, the catheter could not be manipulated.The catheter was retracted from the patient and it was noted that the tip of the catheter was fractured.The catheter was replaced.And the procedure was completed successfully with no patient consequences.
Event or Problem Description
During an accessory pathway procedure, there was a steering issue with the catheter which required replacement.After accessing the left ventricle to map the mitral annulus, the catheter could not be manipulated.The catheter was retracted from the patient and the steering issue was confirmed.The catheter was replaced and the procedure was completed successfully with no patient consequences.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h2, h3, h6.One bi-directional, curve d-f, flexability ablation catheter was received for evaluation along with a video and photo that were submitted to the product performance engineering team.A notable bend in the catheter shaft made the device unable to deflect within specifications.There were no missing parts of the device noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported deflection issue remains unknown.

• 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, COSTA RICA LTDA; 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, COSTA RICA LTDA; 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: 22900438
• Report Number: 3008452825-2025-00421
• Device Sequence Number: 12241451
• Product Code: OAD
• UDI-Device Identifier: 05415067011114
• UDI-Public: (01)05415067011114(10)10593638(17)271031
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 11/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A701125
• Device Catalogue Number: A701125
• Device Lot Number: 10593638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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
• Patient Age: 27 YR
• Patient Sex: Female