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-F
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of a displaced electrode exposing internal wiring found on the catheter during analysis.
Additional Manufacturer Narrative
One uni-directional, curve f, flexability sensor enabled ablation catheter was received for evaluation.It was noted that electrode 2 was displaced exposing the wire at the weld joint.Electrode 2 read as an open circuit.Dissection revealed conductor wire 2 had been fractured and exposed proximal to the weld joint, consistent with the open circuit detected.Electrodes 1 and 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 displace electrode and exposed conductor wire 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: 19840943
• Report Number: 3008452825-2024-00414
• Device Sequence Number: 20802703
• Product Code: OAD
• UDI-Device Identifier: 05415067020048
• UDI-Public: (01)05415067020048(10)9108782(17)260531
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2024

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: 05/31/2026
• Device Model Number: A-FASE-F
• Device Catalogue Number: A-FASE-F
• Device Lot Number: 9108782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2024
• 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: 07/23/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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