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-D
Medical Device Problem Codes	Signal Artifact/Noise (1036); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrioventricular node reentry tachycardia procedure, there were display and noise issues on the catheter resulting in a delay to the procedure.After the catheter was connected to the system and inserted into the patient, it was noted that the shape of the catheter displayed abnormal in the three-dimensional system and there was no potential at electrode 1 and electrode 2.The connection line was checked, the radiofrequency instrument was restarted, and the system was restarted, but with no resolution.The catheter was replaced, and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One uni-directional, curve d, flexibility sensor enabled ablation catheter was received for evaluation.The device met specifications during electrical and polarity testing with no open or short circuits detected.In addition, the catheter shaft deflected when the steering mechanism was actuated and met specifications for curve shape.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the display/noise issues and subsequent delay 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: 19983542
• Report Number: 3008452825-2024-00455
• Device Sequence Number: 2781695
• Product Code: OAD
• UDI-Device Identifier: 05415067020031
• UDI-Public: (01)05415067020031(10)9223294(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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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: 08/31/2026
• Device Model Number: A-FASE-D
• Device Catalogue Number: A-FASE-D
• Device Lot Number: 9223294
• 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: 07/26/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2023
• 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