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

Model Number	A701158
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of a fracture found in the catheter shaft during analysis.The shaft braiding was protruding at the point of the fracture.
Additional Manufacturer Narrative
One uni-directional, curve f, flexability ablation catheter was received for evaluation.Investigation revealed a kink in the shaft material at electrode 3 and it was noted that some of the shaft braiding was protruding from the kink.Dissection revealed conductor wire 2 had been fractured at the kink consistent with the open circuit detected and the reported noise issue.Electrodes 1,3 and 4 met specifications of acceptable resistance values.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the kink at electrode 3 and subsequent protruding shaft braiding remains unknown.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, UNI-D, CURVE 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 ; 6517565400
• MDR Report Key: 22323365
• Report Number: 3008452825-2025-00290
• Device Sequence Number: 15658231
• Product Code: OAD
• UDI-Device Identifier: 05415067011503
• UDI-Public: (01)05415067011503(10)9224275(17)260831
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/24/2025

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 Expiration Date: 08/31/2026
• Device Model Number: A701158
• Device Catalogue Number: A701158
• Device Lot Number: 9224275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2025
• 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: 05/29/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2023
• 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
• Patient Sex: Unknown