MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Model Number	A-FASE-DD
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of a fracture found in the catheter shaft during analysis.
Additional Manufacturer Narrative
One bi-directional, curve d-d, flexability sensor enabled ablation catheter was received for evaluation.Electrodes 1 and 2 read as an open circuit.Conductor wires 1 and 2 were found fractured proximal to electrode 2 due to the break in the shaft, consistent with the open circuit detected and the reported display issue.Electrodes 3-4 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 break in the shaft remains unknown.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿
• Common Device Name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
• Manufacturer (Section D): ST. JUDE 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): ST. JUDE 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: 20268488
• Report Number: 3008452825-2024-00538
• Device Sequence Number: 7315339
• Product Code: OAD
• UDI-Device Identifier: 05415067020055
• UDI-Public: (01)05415067020055(10)9030900(17)260430
• 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): 09/20/2024

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: 04/30/2026
• Device Model Number: A-FASE-DD
• Device Catalogue Number: A-FASE-DD
• Device Lot Number: 9030900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• 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: 08/23/2024
• Initial Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• 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