MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY ABLATION CATHETER, SENSOR ENABLED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	A-FASE-FJ
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Related manufacturer report number: 3005334138-2020-00654.During a vt ablation procedure, noise was noted on the catheter.A second device was attempted, but the same issue occurred.A third device was attempted, and the noise was still present.However, the procedure was continued with the third catheter with the noise present and no adverse consequences to the patient.A clinically significant delay occurred and the patient was given additional anesthesia during the procedure due to this issue.
Additional Manufacturer Narrative
Additional information: d9, g3, g6, h2, h3, h6.One bi-directional, curve f-j, tacticath sensor enabled contact force ablation catheter was received for evaluation.Electrical testing of the returned device determined electrodes 1-4 met specifications for acceptable resistance values with no open or short circuits detected.A simulated ablation test was conducted; however, noise was not present on the distal electrode before, during, or after ablation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported noise issue remains unknown.

• Brand Name: FLEXABILITY ABLATION CATHETER, SENSOR ENABLED
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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
• MDR Report Key: 11089721
• Report Number: 3008452825-2020-00732
• Device Sequence Number: 3684117
• Product Code: OAE
• UDI-Device Identifier: 05415067020086
• UDI-Public: 05415067020086
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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: 05/31/2023
• Device Model Number: A-FASE-FJ
• Device Catalogue Number: A-FASE-FJ
• Device Lot Number: 7545698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TACTICATH SE; TACTICATH SE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Weight: 104